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Despite the integration of salivary inflammatory cytokines into research across the biobehavioral, psychological, clinical, and health-related disciplines, there is little guidance regarding the biospecimen collection, handling, and storage practices that maximize the quality and validity of salivary cytokine data. Furthermore, associations between salivary cytokines and measures related to oral health are rarely assessed and accounted for in studies outside the oral health fields. To address these gaps, we examine the sensitivity of salivary interleukin-1β (IL-1β), IL-6, IL-8, and tumor necrosis factor-α (TNF-α) to changes in saliva sample collection technique and cold chain management procedures. Using subsets of saliva samples collected from 150 healthy adults, we measure salivary IL-1β, IL-6, IL-8, TNF-α, and other oral health-related indices (i.e., blood contamination [transferrin], and salivary matrixmallotprotienase-8). In addition to examining changes in cytokine levels associated with sample collection technique and cold chain management procedures, we assess relations between cytokine concentrations and levels of other oral health-related measures. We found that IL-1β, IL-6, and IL-8 were more robust to changes in sample collection and cold chain management procedures than TNF-α, and all cytokines were positively associated with other oral health-related measures. Based on our findings, we recommend analyte-specific guidance for measuring and interpreting salivary cytokine concentrations.

The PanNET Working Group of the 16th International Multiple Endocrine Neoplasia Workshop (MEN2019) convened in Houston, TX, USA, 27–29 March 2019 to discuss key unmet clinical needs related to PanNET in the context of MEN1, with a special focus on non-functioning (nf)-PanNETs. The participants represented a broad range of medical scientists as well as representatives from patient organizations, pharmaceutical industry and research societies. In a case-based approach, participants addressed early detection, surveillance, prognostic factors and management of localized and advanced disease. For each topic, after a review of current evidence, key unmet clinical needs and future research directives to make meaningful progress for MEN1 patients with nf-PanNETs were identified. International multi-institutional collaboration is needed for adequately sized studies and validation of findings in independent datasets. Collaboration between basic, translational and clinical scientists is paramount to establishing a translational science approach. In addition, bringing clinicians, scientists and patients together improves the prioritization of research goals, assures a patient-centered approach and maximizes patient involvement. It was concluded that collaboration, research infrastructure, methodologic and reporting rigor are essential to any translational science effort. The highest priority for nf-PanNETs in MEN1 syndrome are (1) the development of a data and biospecimen collection architecture that is uniform across all MEN1 centers, (2) unified strategies for diagnosis and follow-up of incident and prevalent nf-PanNETs, (3) non-invasive detection of individual nf-PanNETs that have an increased risk of metastasis, (4) chemoprevention clinical trials driven by basic research studies and (5) therapeutic targets for advanced disease based on biologically plausible mechanisms.

Circulating cell-free DNA (cfDNA) is rapidly transitioning from discovery research to an important tool in clinical decision making. However, the lack of harmonization of preanalytic practices across institutions may compromise the reproducibility of cfDNA-derived data and hamper advancements in cfDNA testing in the clinic. Differences in cellular genomic contamination, cfDNA yield, integrity, and fragment length have been attributed to different collection tube types and anticoagulants, processing delays and temperatures, tube agitation, centrifugation protocols and speeds, plasma storage duration and temperature, the number of freeze-thaw events, and cfDNA extraction and quantification methods, all of which can also ultimately impact subsequent downstream analysis. Thus, there is a pressing need for widely applicable standards tailored for cfDNA analysis that include all preanalytic steps from blood draw to analysis. The NCI's Biorepositories and Biospecimen Research Branch has developed cfDNA-specific guidelines that are based upon published evidence and have been vetted by a panel of internationally recognized experts in the field. The guidelines include optimal procedures as well as acceptable alternatives to facilitate the generation of evidence-based protocols by individual laboratories and institutions. The aim of the document, which is entitled “Biospecimen Evidence-based Best Practices for Cell-free DNA: Biospecimen Collection and Processing,” is to improve the accuracy of cfDNA analysis in both basic research and the clinic by improving and harmonizing practices across institutions.

Historical theories of metastasis have been informed by the seed and soil hypothesis, the Halsteadian paradigm proposing an orderly spread from local to distant sites, and the presumption that cancer is an inherently systemic process even in the earliest cases. The more contemporary spectrum theory now suggests that the propensity for distant spread exists along a continuum of metastatic virulence. Tumors with limited metastatic potential represent one subset along this spectrum that could potentially be cured with local ablative therapy. Integrating clinical and molecular features to biologically inform the classification of not only oligometastatic or oligoprogressive disease but also the entire metastatic spectrum holds great promise to improve prognostication and inform clinical decision making. To this end, the inclusion of molecular correlative studies and biospecimen collection on prospective protocols is imperative.

Amyotrophic lateral sclerosis (ALS) is a rare neurological condition affecting upper and lower motor neurons. The National ALS Biorepository (referred to as the Biorepository) was initiated in 2015, with biospecimen collection beginning in 2017, as a repository for biospecimens for future ALS research. To help ensure the usefulness of the Biorepository, a biospecimen demand analysis is conducted on an annual basis, as well as an analysis of the utilization of the Biorepository. To determine the types of biospecimens to be collected for the Biorepository, an in-depth initial examination occurred followed by ongoing biospecimen demand and utilization analyses. The initial examination included input from an expert panel, discussions with ALS research experts, review of other ALS biorepositories, assessment of biospecimen demand, and analysis of the biospecimen types historically used in ALS research. Of all biospecimen types reported in the literature, the most frequently used were DNA, postmortem spinal cord, blood, and cerebrospinal fluid; while the frequently reported types of biospecimens used in ALS-related grants were induced pluripotent stem cells, brain, blood, and spinal cord. Continuous analysis of potential sample demand and tissues collected, based on an analysis of the literature and funded grants, and actual sample requests can assist the Biorepository in ensuring that the appropriate samples are available for researchers when they are needed.

International collaboration in oncology trials has the potential to enhance clinical trial activity by expediting the recruitment of large patient populations, testing treatments in diverse populations and facilitating the study of rare tumours or specific molecular subtypes. However, a number of challenges continue to hinder the efficient and productive conduct of both commercial and non-commercial international clinical trials. These challenges include complex and burdensome regulatory requirements, the high cost of conducting trials, and logistical challenges associated with ethics review, drug supply and biospecimen collection and management. We propose solutions to promote oncology trial collaboration, such as regulatory reform, harmonisation of trial initiation and management processes and greater recognition and funding of academic (non-commercial) clinical trials. It is only through coordinated effort and leadership from researchers, regulators and those responsible for health systems that the full potential of international trial collaboration can be realised.

This is a description of the steps that the Washington University in St. Louis HTAN center has developed to collect surgical resection biospecimens, for molecular and genomic characterization. There are two separate protocols because the technique has evolved and better methods for tumor sampling have been developed. This is the second sample protocol and employs an innovative grid system for sampling.

Highlights • Willingness to donate biospecimens was related to past donation. • Trust in how researchers would use and store biospecimens influenced willingness. • Fear of research exploitation and spiritual beliefs decreased willingness. • Willingness increased if the biobank was run by a Native American organization. • Willingness decreased if the biobank was run by the federal government., American Indian and Alaska Native (AI/AN) people are underrepresented in biomedical research, particularly in biospecimen research, yet little research has been conducted to assess AI/AN attitudes about biospecimen donation. Survey data were collected from 278 AI/AN people in Seattle, Washington in 2016 to assess general willingness to donate, background characteristics related to willingness, and circumstances that would increase or decrease willingness to donate biospecimens. Less than half (43%) of participants were willing to donate. General willingness was related to past donation, and trust in how researchers use and store biospecimens. However, willingness to donate for cancer research was 76%. Fear of research exploitation and spiritual beliefs decreased willingness. Among those who were generally unwilling to donate, willingness increased if the biobank was run by a Native American organization, if the participant or family member had cancer and this was the disease being studied, if the community was involved in developing, reviewing, and approving the research, and if the expertise of researchers was known. Among those who were willing, willingness decreased if they had never heard of the research organization, and if the biobank was run by the federal government. Participation of AI/AN people in biobanking initiatives is critical to address health inequities and improve the health of AI/AN people, realize personalized medicine goals, and address the limited generalizability of current clinical and biospecimen research. These results highlight areas in which interventions could be developed to increase AI/AN donation of biospecimens for research with the ultimate goal of reducing health disparities.

Immunotherapy is now a cornerstone for cancer treatment, and much attention has been placed on the identification of prognostic and predictive biomarkers. The success of biomarker development is dependent on accurate and timely collection of biospecimens and high-quality processing, storage and shipping. Tumors are also increasingly used as source material for the generation of therapeutic T cells. There have been few guidelines or consensus statements on how to optimally collect and manage biospecimens and source material being used for immunotherapy and related research. The Society for Immunotherapy of Cancer Surgery Committee has brought together surgical experts from multiple subspecialty disciplines to identify best practices and to provide consensus on how best to access and manage specific tissues for immuno-oncology treatments and clinical investigation. In addition, the committee recommends early integration of surgeons and other interventional physicians with expertise in biospecimen collection, especially in clinical trials, to optimize the quality of tissue and the validity of correlative clinical studies in cancer immunotherapy.

This study aims to assess the validity and reproducibility of a culture-specific semi-quantitative food frequency questionnaire (FFQ) for Lebanese adults. The 94-item FFQ captures intake of traditional Mediterranean dishes and Western food, reflective of current Lebanese nutrition transition. Among 107 participants (18&ndash, 65 years), the FFQ was administered at baseline (FFQ-1) and one year thereafter (FFQ-2), 2&ndash, 3 24-h recalls (24-HRs)/season were collected for a total of 8&ndash, 12 over four seasons. A subset (n = 67) provided a fasting blood sample in the fall. Spearman-correlation coefficients, Bland&ndash, Altman plots, joint-classification and (ICC) were calculated. Mean intakes from FFQ-2 were higher than from the total 24-HRs. Correlations for diet from FFQ-2 and 24-HRs ranged from 0.17 for &alpha, carotene to 0.65 for energy. Joint classification in the same/adjacent quartile ranged from 74.8% to 95%. FFQ-2-plasma carotenoid correlations ranged from 0.18 for lutein/zeaxanthin to 0.59 for &beta, carotene. Intra-class correlations for FFQ-1 and FFQ-2 ranged from 0.36 for &beta, cryptoxanthin to 0.85 for energy. 24-HRs carotenoid intake varied by season, combining season-specific 24-HRs proximal to biospecimen collection to the FFQ-2 improved diet-biochemical correlations. By applying dietary data from two tools with biomarkers taking into consideration seasonal variation, we report a valid, reproducible Lebanese FFQ for use in diet-disease research.

PURPOSE OF REVIEW. The advent of low-volume biosampling and novel biomarker matrices offers non- or minimally-invasive approaches to sampling in children. These new technologies, combined with advancements in mass spectrometry that provide high-sensitivity, robust measurements of low-concentration exposures, facilitate the application of untargeted metabolomics in children’s exposome research. Here, we review emerging sampling technologies for alternative biomatrices—dried capillary blood, interstitial fluid, saliva, teeth, and hair—and highlight recent applications of these samplers to drive discovery in population-based exposure research. RECENT FINDINGS. Biosampling and biomarker technologies demonstrate potential to directly measure exposures during key developmental time periods. While saliva is the most traditional of the reported biomatrices, each technology has key advantages and disadvantages. For example, hair and teeth provide retrospective analysis of past exposures, and dried capillary blood provides quantitative measurements of systemic exposures that can be more readily compared to traditional venous blood measurements. Importantly, all technologies can or have the potential to be used at home, increasing the convenience and parental support for children’s biosampling. SUMMARY. This review describes emerging sample collection technologies that hold promise for children’s exposome studies. While applications in metabolomics are still limited, these novel matrices are poised to facilitate longitudinal exposome studies to discover key exposures and windows of susceptibility affecting children’s health.

Patients afflicted with pancreatic ductal adenocarcinoma (PDAC) face a dismal prognosis, but headway could be made if physicians could identify the disease earlier. A compelling strategy to broaden the use of surveillance for PDAC is to incorporate molecular biomarkers in combination with clinical analysis and imaging tools. This article summarizes the components involved in accomplishing biomarker validation and an analysis of the requirements of molecular biomarkers for disease surveillance. We highlight the significance of consortia for this research and highlight resources and infrastructure of the Early Detection Research Network (EDRN). The EDRN brings together the multifaceted expertise and resources needed for biomarker validation, such as study design, clinical care, biospecimen collection and handling, molecular technologies, and biostatistical analysis, and studies coming out of the EDRN have yielded biomarkers that are moving forward in validation. We close the article with an overview of the current investigational biomarkers, an analysis of their performance relative to the established benchmarks, and an outlook on the current needs in the field. The outlook for improving the early detection of PDAC looks promising, and the pace of further research should be quickened through the resources and expertise of the EDRN and other consortia.See all articles in this CEBP Focus section, “NCI Early Detection Research Network: Making Cancer Detection Possible.”

Despite intensive investigation, we still cannot adequately predict, treat, or prevent preeclampsia. We have gained awareness that preeclampsia is a syndrome not a disease and is heterogeneous in its presentation and pathophysiology, which may indicate differing underlying phenotypes, and that the impact extends beyond pregnancy per se. Effects on the fetus and mother extend many years after pregnancy, as evidenced by fetal programming of adult disease and increased risk of the development of maternal cardiovascular disease. The increased occurrence of preeclampsia in women with preexisting risk factors suggests that the stress of pregnancy may expose subclinical vascular disease as opposed to preeclampsia damaging the vasculature. The heterogeneity of preeclampsia has blighted efforts to predict preeclampsia early in gestation and has thwarted success in attempts at therapy with treatments, such as low-dose aspirin or global antioxidants. There is a critical need to identify the phenotypes to enable their specific prediction and treatment. Such studies require considerably larger collections of patients than employed in past and current studies. This does not necessarily imply much larger patient numbers in single studies but can be facilitated by the ability to easily combine many smaller studies. This can be accomplished by agreeing on a priori standardized and harmonized clinical data and biospecimen collection across new studies. Such standards are being established by international groups of investigators. Leadership by international organizations, perhaps adopting a carrot and stick approach, to overcome investigator, institutional and funder reticence toward data sharing is required to ensure adoption of such standards. Future studies should include women in both low- and high-resource settings and employ social media and novel methods for data collection and analysis, including machine learning and artificial intelligence. The goal is to identify the pathophysiology underlying differing preeclampsia phenotypes, their successful prediction with the design, and the implementation of phenotype-specific therapies.

Biospecimen collection in the Adolescent Brain Cognitive Development (ABCD) study – of hair samples, shed deciduous (baby) teeth, and body fluids – will serve dual functions of screening for study eligibility, and providing measures of biological processes thought to predict or correlate with key study outcomes on brain and cognitive development. Biosamples are being collected annually to screen for recency of drug use prior to the neuroimaging or cognitive testing visit, and to store for the following future studies: (1) on the effects of exposure to illicit and recreational drugs (including alcohol and nicotine); (2) of pubertal hormones on brain and cognitive developmental trajectories; (3) on the contribution of genomics and epigenomics to child and adolescent development and behavioral outcomes; and (4) with pre- and post-natal exposure to environmental neurotoxicants and drugs of abuse measured from novel tooth analyses. The present manuscript describes the rationales for inclusion and selection of the specific biospecimens, methodological considerations for each measure, future plans for assessment of biospecimens during follow-up visits, and preliminary ABCD data to illustrate methodological considerations. Keywords: Biospecimens, ABCD study, Substance use, Gonadal hormones, Genetics, Environmental exposures

Introduction: The gut microbiome is a potentially modifiable factor in treatment related outcomes in allogeneic hematopoietic cell transplant (HCT). Prior studies have linked pre- or mid-treatment gut microbiome diversity with risk for treatment related morbidity and mortality. However, these studies have been limited by the inclusion of one or only a few institutions and the lack of longitudinal sampling with high quality metadata. These limitations complicate the interpretation of microbiome alterations over the course of HCT. Methods: To overcome these, we devised and implemented a large-scale biospecimen collection protocol in conjunction with BMT CTN 1703, a randomized, multicenter, Phase III trial of tacrolimus/methotrexate vs. post-transplant cyclophosphamide/tacrolimus/mycophenolate mofetil in reduced intensity conditioning (RIC) allogeneic HCT (NCT03959241). Patients enrolled on 1703 were optionally co-enrolled in the companion immune and microbiome profiling study, 1801 (MI-IMMUNE). This involved blood, urine and stool sampling before conditioning (PCON), then weekly starting on day 0 through day 77 (through day 84 for blood), and on days 98, 180, 270, 365 and 730. For all enrolled participants where the donor consented, residual donor cells were saved from the empty hematopoietic stem cell product bag for later analysis. Additionally, the protocol included one-time blood, urine and stool sample collection from consented matched related donors (MRDs) prior to stem cell collection. Starting with protocol version 4.0 on February 1, 2021, participation in 1801 stool collection was required for the first six out of eighteen sample collection timepoints. Participation in later stool and urine timepoint collections remained optional. Here we review the feasibility of creating a multi-institutional biobank. Additionally, we assess the success of our strategies by calculating sample collection compliance and standard deviation in compliance across centers for each timepoint. Results: On June 18, 2021, BMT CTN 1703/1801 closed to accrual with 431 patients enrolled on 1703; 323 patients from 36 centers were co-enrolled on 1801. 304 (94%) provided study samples, making this the largest prospective microbiome and immune profiling study in HCT patients to date. As of July 6, 2021, 3,683 blood, 2,668 urine, and 2,098 stool samples had been collected. Across the first 6 timepoints for all participating centers, blood, urine and stool sample collection averaged 93%, 82%, and 74% compliance, respectively. Of the 99 (30%) patients enrolled on 1801 with a MRD, 34 (34%) donors consented to sample collection. Sample collection compliance was lower for MRDs than for patients on the study with 76%, 74%, and 62% of expected blood, urine and stool samples collected, respectively, from this group. For stool collection exclusively, a median of 5 samples were collected per patient across the first 6 timepoints (median of 6 across all timepoints) with 93 (31%) of patients completing a full sample set through Day 28. 139 (46%) patients provided at least one sample after day 28; these represented 37% of the total samples collected to date. The PCON sample, which provides an important measure of pre-treatment gut microbiome diversity, had the third highest compliance with 74% of patients providing a sample. Surprisingly, Day 28 had the lowest compliance (66%) and highest standard deviation (37%) possibly because this timepoint often falls around the time of hospital discharge. Between PCON and day 28, the standard deviation between sites in the average collection compliance (24%) and number of samples collected per patient (1.1) was small indicating the successful adoption of stool collection across institutions. Table 1 summarizes sample collection statistics. Conclusion: Overall this study has resulted in a large, novel biobank of blood, urine and stool samples from patients undergoing RIC allogeneic HCT at 36 centers across the US. This will serve as a valuable resource for investigating the role of the gut microbiome in long term health outcomes following HCT. Although the results of 1801 are forthcoming given ongoing sample collection, the size and composition of the biobank to date clearly demonstrate the feasibility of implementing multi-institutional stool collection. This study represents a critical step towards the large-scale adoption of microbiome sampling as a diagnostic tool. Figure 1 Figure 1. Disclosures Chhabra: GSK: Honoraria. Clark: Kadmon: Consultancy. Horowitz: Mesoblast: Research Funding; Shire: Research Funding; Vertex: Research Funding; Stemcyte: Research Funding; Vor Biopharma: Research Funding; Janssen: Research Funding; Miltenyi Biotech: Research Funding; Kiadis: Research Funding; Sobi: Research Funding; Kite/Gilead: Research Funding; Pfizer, Inc: Research Funding; Jazz Pharmaceuticals: Research Funding; Magenta: Consultancy, Research Funding; Medac: Research Funding; Novartis: Research Funding; GlaxoSmithKline: Research Funding; Daiicho Sankyo: Research Funding; Xenikos: Research Funding; Omeros: Research Funding; Orca Biosystems: Research Funding; Pharmacyclics: Research Funding; Regeneron: Research Funding; Tscan: Research Funding; Takeda: Research Funding; CSL Behring: Research Funding; Genentech: Research Funding; Gamida Cell: Research Funding; Chimerix: Research Funding; Bristol-Myers Squibb: Research Funding; bluebird bio: Research Funding; Astellas: Research Funding; Amgen: Research Funding; Allovir: Consultancy; Actinium: Research Funding; Sanofi: Research Funding; Seattle Genetics: Research Funding. Jenq: Microbiome DX: Consultancy; Merck: Consultancy; Prolacta: Consultancy, Membership on an entity's Board of Directors or advisory committees; Kaleido: Consultancy, Current holder of stock options in a privately-held company, Membership on an entity's Board of Directors or advisory committees, Research Funding; Seres: Consultancy, Current holder of stock options in a privately-held company, Membership on an entity's Board of Directors or advisory committees, Patents & Royalties, Research Funding; LisCure: Consultancy, Membership on an entity's Board of Directors or advisory committees; MaaT Pharma: Consultancy, Membership on an entity's Board of Directors or advisory committees; Karius: Consultancy. Levine: Equillium Bio: Membership on an entity's Board of Directors or advisory committees; Incyte: Consultancy, Research Funding; Kamada: Research Funding; Biogen: Research Funding; Omeros: Membership on an entity's Board of Directors or advisory committees; Symbio: Membership on an entity's Board of Directors or advisory committees; Jazz Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees; Talaris Therapeutics: Membership on an entity's Board of Directors or advisory committees; Viracor: Patents & Royalties: GVHD biomarker patent with royalties from Viracor; Mesoblast: Consultancy, Research Funding; X4 Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees. Murthy: CRISPR Therapeutics: Research Funding. Riches: ATARA Biotherapeutics: Other: Payment; BioIntelect: Membership on an entity's Board of Directors or advisory committees; Jazz Pharmaceuticals: Other: Payment. Sung: Merck: Research Funding; Novartis: Research Funding; Enterome: Research Funding; Seres: Research Funding; AVROBIO: Consultancy; Abbott Nutrition: Honoraria; Clasado: Other: Research Product; DSM: Other: Research Product. Al Malki: Neximmune: Consultancy; Jazz Pharmaceuticals, Inc.: Consultancy; Rigel Pharma: Consultancy; Hansa Biopharma: Consultancy; CareDx: Consultancy. Rezvani: Kaleido: Other: One-time scientific advisory board; Nohla Therapeutics: Other: One-time scientific advisory board; Pharmacyclics-Abbvie: Research Funding; US Department of Justice: Consultancy. Bolaños-Meade: Incyte Corp: Consultancy. Holtan: Incyte: Consultancy, Research Funding; Generon: Consultancy. Saber: Govt. COI: Other. Hamadani: Sanofi, Genzyme, AstraZeneca, BeiGene: Speakers Bureau; Janssen, Incyte, ADC Therapeutics, Omeros, Morphosys, Kite: Consultancy; Takeda, Spectrum Pharmaceuticals and Astellas Pharma: Research Funding. Kean: Bluebird Bio: Research Funding; Bristol Myers Squibb: Patents & Royalties: From clinical trial data, Research Funding; Vertex: Consultancy; Novartis: Consultancy; Gilead: Research Funding; Regeneron: Research Funding; EMD Serono: Consultancy. Perales: Cidara: Honoraria; Servier: Honoraria; Incyte: Honoraria, Other; Equilium: Honoraria; Takeda: Honoraria; Novartis: Honoraria, Other; Nektar Therapeutics: Honoraria, Other; NexImmune: Honoraria; MorphoSys: Honoraria; Omeros: Honoraria; Karyopharm: Honoraria; Sellas Life Sciences: Honoraria; Merck: Honoraria; Miltenyi Biotec: Honoraria, Other; Medigene: Honoraria; Bristol-Myers Squibb: Honoraria; Kite/Gilead: Honoraria, Other; Celgene: Honoraria.

High-quality biospecimen collection from consented patients is crucial for cancer research activities. Patients' attitudes and willingness toward specimen donation influence high-quality biospecimen collection for cancer research activities.We carried out a cross-sectional study among randomly selected patients from 11 cancer departments of Tianjin Medical University Cancer Institute and Hospital between August 2014 and August 2015. A total of 784 patients were included to complete a 30-item self-administered survey. We evaluated the patients' willingness to consider providing leftover samples and additional samples for cancer research purposes.Among 784 patients, 683 (87.1%) and 653 (83.3%) were willing to donate leftover tissue and surplus blood after diagnosis, respectively. Six hundred thirty-one (80.5%) were favorably disposed to consider donating both tissue and blood samples for future cancer research. Female patients showed less willingness to donate biospecimens or related clinical data for research. First-hospitalized or older patients were less willing to provide leftover biospecimens or additional blood samples or even clinical data for research. By contrast, patients with a higher education level were more likely to donate leftover tissues after biopsy or surgery for research activities.Most Chinese cancer patients were willing to consider donating blood and tissue samples for cancer research. Several factors, including age, gender, first hospitalization, and education level, can influence their willingness to donate biospecimens. We need to provide proper education to increase understanding of patients in biobanking activities.This study provides novel empirical data on the likelihood of donating surplus and additional biospecimens and clinical health information among Chinese cancer patients.

Background GetCheckedOnline (GCO) is a comprehensive, online sexually-transmitted infection (STI) testing service in British Columbia, Canada, which includes urine nucleic acid amplification testing (NAAT) for chlamydia (CT) and gonorrhea (GC). In 2016, responding to mounting evidence of missed infections with urine-only screening, self-collected throat and rectal swabs were added. We aimed to describe missed infections with urine-only screening. Methods We retrospectively analyzed all CT/GC-related testing episodes conducted through GCO in 2016–2018. Urine testing is recommended for all GCO clients. Rectal swabs are recommended to clients reporting receptive anal sex in the past 3 months; throat swabs are recommended to men who have sex with men (MSM) who indicate giving oral sex in the past 3 months. We described prevalence by site and quantified the proportion of CT/GC infections missed with urine-only screening. Results Of 10,724 CT/GC urine test episodes, 2746 (25.6%) and 2288 (21.3%) included throat and rectal swabs, respectively. 95.0% and 86.0% of clients recommended for throat and rectal swab testing submitted samples, respectively. Among women, 3760 CT/GC urine test episodes were conducted, with 560 (14.9%) including rectal swabs. Percent positivity by infection-site was 3.6% CT-urine, 3.0% CT-rectal, 0.1% GC-urine, and 0.2% GC-rectal. Urine testing alone detected 95.3% of CT/GC infections. Among MSM, 3088 CT/GC urine test episodes were conducted, with 2587 (83.8%) including throat swabs and 1635 (52.9%) including rectal swabs. Percent positivity by infection-site was 1.5% CT-urine, 0.7% CT-throat, 5.1% CT-rectal, 0.5% GC-urine, 2.4% GC-throat, and 2.8% GC-rectal. Urine testing alone detected only 25.4% of all CT/GC infections. Conclusion The majority of GCO clients recommended for self-collected throat and rectal swabs submitted samples. Approximately three-quarters of CT/GC infections among MSM would have been missed if swabs had not been offered. Online STI testing services should provide comprehensive biospecimen collection when indicated to facilitate CT/GC detection and treatment. Disclosure No significant relationships.

INTRODUCTION: Development of clinical biomarkers to guide therapy is an important unmet need in aneurysmal subarachnoid hemorrhage (SAH). A wide spectrum of plausible biomarkers has been reported for SAH, but none have been validated due to significant variabilities in study design, methodology, laboratory techniques, and outcome endpoints. METHODS: A systematic review of SAH biomarkers was performed per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The panel’s recommendations focused on harmonization of (1) target cellular and molecular biomarkers for future investigation in SAH, (2) standardization of best-practice procedures in biospecimen and biomarker studies, and (3) experimental method reporting requirements to facilitate meta-analyses and future validation of putative biomarkers. RESULTS: No cellular or molecular biomarker has been validated for inclusion as “core” recommendation. Fifty-four studies met inclusion criteria and generated 33 supplemental and emerging biomarker targets. Core recommendations include best-practice protocols for biospecimen collection and handling as well as standardized reporting guidelines to capture the heterogeneity and variabilities in experimental methodologies and biomarker analyses platforms. CONCLUSION: Significant variabilities in study design, methodology, laboratory techniques, and outcome endpoints exist in SAH biomarker studies and present significant barriers toward validation and translation of putative bio-markers to clinical use. Adaptation of common data elements, recommended biospecimen protocols, and reporting guidelines will reduce heterogeneity and facilitate future meta-analyses and development of validated clinical biomarkers in SAH.

PURPOSES: To examine whether (a) non-minority participants differed from racial minority participants in the understanding of biospecimens collected for research purposes, (b) patients differed from comparison-group in their understanding of the ways their biospecimens could be used by researchers, and (c) participants received adequate information before consenting to donate blood for research studies. METHODS: We analyzed cross-sectional data from female breast cancer patients scheduled to receive chemotherapy at National Cancer Institute (NCI) Community Oncology Research Program (NCORP) clinical sites and a healthy comparison group. After reading a consent form related to biospecimens and consenting to participate in a clinical trial, participants’ understanding of biospecimen collection was evaluated. Linear models were used to compare scores between non-minority and racial minority participants as well as cancer and non-cancer comparisons adjusting for possible confounding factors. RESULTS: A total of 650 participants provided evaluable data; 592 were non-minority (Caucasian) and 58 participants were racial minority (71% black and 29% other). There were 427 cancer patients and 223 comparisons. Non-minority participants scored higher than racial minorities on relevance-to-care items (diff.=0.48, CI: 0.13 – 0.80, p=0.001). Comparison group scored higher than cancer patients on relevance-to-care items (diff.=0.58, CI: 0.37–0.78). CONCLUSION: A moderate number of the participants exhibited poor understanding of biospecimen collection across all racial/ethnic backgrounds, but racial minority participants’ scores remained lower in the relevance-to-care subscale even after adjusting for education and reading level. Differences were also noted among the patients and comparison group. Researchers should facilitate comprehension of biospecimen collection for all study participants, especially racial minority participants.

Background: The intestinal microbiome plays an important role in the development of acute graft-versus-host disease (aGVHD). However, it is not well known whether the intestinal microbiota at neutrophil engraftment could predict the occurrence and grades of aGVHD. Methods: We collected stool and blood samples from 141 patients undergoing allogeneic hematopoietic stem cell transplantation. The microbiota, the inflammatory factors and T lymphocyte subsets were detected at pre-conditioning, day 0 and day 15 post-transplantation. The abundance of bacterial that could predict aGVHD and diversity were included in accumulated intestinal microbiota (AIM) score. Findings: We found microbiota diversity was associated with conditioning (P = 0.017, day 0 and P = 0.045, day 15) and β-lactam antibiotics (P = 0.004, day 15). Treg/Th17 ratio was positively correlated with microbial diversity (r = 0.216, P = 0.010), while it was negatively correlated with levels of TNF-α, IL-17A, IL-1β and LPS in plasma (r = -0.226, -0.225, -0.335, -0.291; P = 0.007, 0.010, < 0.001, < 0.001, respectively) at day 15. The accumulated intestinal microbiota (AIM) score at day 15 could be a predictor for the development of aGVHD (II-IV aGVHD: AUC = 0.75, P < 0.001; III-IV aGVHD: AUC = 0.84, P < 0.001). AIM score was also correlated with aGVHD grades (r = 0.481, P < 0.001). Interpretations: These findings suggest intestinal microbiota and conditioning might induce aGVHD by inflammatory factors and influence Treg/Th17 balance. The constitution of the intestinal microbiota at neutrophil engraftment may predict the development and grades of aGVHD. Funding: This work was funded by the National Natural Science Foundation of China (Nos. U1401221, 81770190, 81870144, 81600141, 81700176, and 81470349), the National primary research plan (Nos. 2017YFA105500 and 2017YFA105504). Science and Technology Major Planning Project of Guangdong Province (2014B020226004), Natural Science Foundation of Guangdong Province (No.2016A030310390), and Medical Science and Technology Planning Project of Henan Province (201403227). Declaration of Interest: The authors declare no competing financial interests. Ethical Approval: This study was approved by the ethical committee of the Nanfang Hospital, Southern Medical University, China. After approval of the study, the consent of the participants was signed for biospecimen collection and analysis. This study was conducted in accordance with the Declaration of Helsinki.

Biobanks are critical resources for biomedical research and will be a driving force behind personalized medicine. Although biobanking efforts are increasing across the USA and the world, minority populations are frequently underrepresented in biobanks, which undermines their value. A number of factors have been linked to low rates of minority participation in biobanks, including mistrust of researchers, concerns about privacy and confidentiality, logistical barriers to participation, and inadequate opportunities to participate. There are several strategies biobankers can use to increase participation of minority and underserved populations and optimize the value of their biospecimen collection for research.

This study tested the feasibility of collecting saliva samples from Pacific Islanders (PIs) via a community-based participatory research approach. Collection of saliva samples were conducted by trained and trusted PI community leaders at various partner sites. A total of 214 saliva samples were donated by PIs living in Southern California, more than half of whom were females between the ages of 18 and 35 years. Donors indicated that they donated because they wanted to help science and their community. A majority of donors reported a very positive experience with the donation process and were willing to donate saliva and hair samples in the future. The positive findings of this article highlight the importance of community input and participation.

Variable and suboptimal biospecimen handling practices have been identified as impediments to biomarker discovery,1,2 including predictive biomarkers for oncology3 indicating a clear and present need for evidence-based, standardized practices. The United States and international efforts have been launched to better understand and mitigate variability during the preanalytical phase and decrease associated effects by promoting harmonization of procedures both within and across institutions. The Biorepositories and Biospecimen Research Branch (BBRB) of the United States National Cancer Institute (NCI) publishes best practice documents aimed at improving the quality of data generated from human biospecimens (https://biospecimens.cancer.gov/bestpractices/overview.asp) and sponsors research initiatives (https://biospecimens.cancer.gov/programs/default.asp) and the Biospecimen Research Database (BRD; http://biospecimens.cancer.gov/brd) to better understand thresholds and effects of individual preanalytical factors in biospecimen handling. The BRD allows users to query both a curated literature repository and standard operating procedure (SOP) library for a specific preservative, diagnosis, analyte, or preanalytical factor. The BRD incorporates information from international efforts, including those by the International Society for Biological and Environmental Repositories (ISBER) and the European Union-sponsored SPIDIA program (standardization and improvement of generic preanalytical tools and procedures for in vitro diagnostics; www.spidia.eu), among others. To facilitate the implementation of evidence-based practices in biospecimen handling, BBRB has developed a document series termed Biospecimen Evidence-Based Practices (BEBP), which contains step-by-step procedural guidelines derived from peer-reviewed primary research articles and expert experience.4 The aim of the BEBP series is to promote a practical level of standardization and improve overall biospecimen quality and data reproducibility by specifying both optimal methods and suitable alternatives, while merging published evidence with practical knowledge of experts in the field. The intent of the BEBP is not to serve as a SOP, but to facilitate the development of evidence-based SOPs by individual laboratories. The present BEBP focuses on nucleic acid extraction from formalin-fixed, paraffin-embedded (FFPE) tissue biospecimens (see Supplementary Data; Supplementary Data are available online at www.liebertpub.com/bio). Such biospecimens are being increasingly utilized in genomic research, and it has become clear over the past decade that variable and suboptimal FFPE biospecimen collection and processing practices can alter the quantity and/or quality of extracted DNA and RNA.5 Concordance between the molecular data generated with FFPE and snap-frozen biospecimens varies widely among reports, with correlations ranging from weak to very strong for the same analytical method.6 While lack of concordance may be partially attributable to differences in biospecimen handling during FFPE processing, available evidence suggests that the extraction method can compound or mitigate effects introduced during biospecimen collection, processing, and storage, thus affecting the suitability of samples for downstream analysis.7–11 When deciding on a nucleic acid extraction procedure, it is paramount to consider artifacts that may have been introduced during formalin fixation and processing, such as nucleic acid fragmentation,12 nucleic acid–protein crosslinking,13,14 denaturation,15,16 and additions of methylol groups to nucleic acids.15,17 Importantly, many such formalin-induced modifications to DNA and RNA are reversible13,18–21; for example, the addition of a demodification step as well as optimization of multiple steps during the extraction procedure can attenuate effects introduced during fixation and processing. However, FFPE-specific optimization steps are interdependent and must be considered collectively when developing a strategy for extraction. While several commercial extraction kits are marketed as being tailored for FFPE biospecimens, experts contributing to the BEBP advised validating any kit for the intended tissue type, processing regime, and analytical platform before implementation in experimental studies. Validation includes experiments to confirm the feasibility and accuracy of the intended analytical use, the reproducible performance of the kit, and the robustness to processing regimes.

The much-anticipated promise of personalized cancer care is to deliver therapies best suited for a patient based on the knowledge of that individual’s genetics and tumor characteristics. This transformative approach will require many changes in the scientific and medical community, one of the most fundamental being the direct study of human tissue biospecimens. Biospecimens will be integral to the elucidation of biomarkers that will help identify and serve as potential diagnostic, prognostic and therapeutic targets in cancer. Despite the vast repositories of fixed-tissue biospecimens that are in existence, a number of flaws exist that hinder their reliable use as instruments from which to enable personalized cancer research and clinical care. A new view of biospecimen worth in the future will mandate that the molecules within its cells are reflective of their in vivo state, and not altered by external variables introduced during the excision and processing of the biospecimen. Research on biospecimen collection is a legitimate field of study that will be necessary for personalized cancer care to become a reality.

Semi-volatile organic compounds (SVOCs) are used extensively in consumer and personal care products; electronics; furniture; and building materials and are detected in most indoor environments. As a result, human exposure to mixtures of SVOCs is wide-spread. However, very few studies have measured biomarkers of exposure to multiple SVOC classes, and exposure determinants have not been thoroughly explored, particularly for young children. In this study, we investigated biomarkers of exposure to SVOCs among children (age 3–6 years), who may experience higher exposures and be more susceptible to adverse health outcomes than other age groups. We enrolled 203 participants in the Toddlers Exposure to SVOCs in Indoor Environments (TESIE) study (181 provided urine samples and 90 provided serum samples).We quantified 44 biomarkers of exposure to phthalates, organophosphate esters (OPEs), parabens, phenols, antibacterial agents and per- and polyfluoroalkyl substances (PFASs); we detected 29 of the 44 biomarkers in >95% of samples, and many biomarkers were detected at higher median concentrations than those previously reported in the U.S. general population. Demographic characteristics were associated with differences in concentrations. In general, non-Hispanic white race and higher maternal education were associated with lower concentrations, even after adjusting for other potential confounding variables. Our results suggest that outdoor temperature at the time of biospecimen collection may be a particularly important and under-evaluated predictor of biomarker concentrations; statistically significant relationships were observed between 10 biomarkers and outdoor temperature at the time of collection. A complex correlation structure was also observed among the biomarkers assessed. By and large, statistically significant correlations between biomarkers of exposure to phthalates, parabens, phenols, and OPEs were positive. Conversely, although PFASs were positively correlated with one another, they tended to be negatively correlated with other biomarkers where significant associations were observed. Taken together, our results provide evidence that the assessments of SVOC-associated health impacts should focus on chemical mixtures.

Poor nutrition during the early stages of human development can lead to rare pathological conditions in adult life. The best-known and most severe historical cases of famine include the Dutch 'Hunger Winter,' the Finnish famine, the Chinese Great famine, and the siege of Leningrad. The siege of Leningrad (now Saint Petersburg) was one of the longest in history, lasting 872 days, from September 8, 1941 to January 27, 1944. There were 670,000 registered deaths of the civil population, in which 97% died due to starvation. The aim of the present study is to create a collection of biospecimens from extensively phenotyped siege of Leningrad survivors, who underwent starvation during the early periods of their lives, and from a matched control group.A total 305 siege survivors and 51 age- and sex- matched control subjects were investigated in of an observational retroprospective cohort study in 2009-2011 at a baseline visit. After 3 years of follow-up, 252 siege survivors (182 females and 70 males; mean age 74.7 ± 2.6 years) and 45 controls (32 females and 13 males; mean age 75.5 ± 2.8 years) were examined. All siege survivors were exposed to the extreme dietary restriction and stress associated with the siege in their early childhood. All participants signed informed consent and were subject to questionnaires and physical examination, as well as various laboratory and instrumental tests. Anthropometry, blood measurement, cognitive and physiological testing, and vascular damage assessment were performed.Blood specimens of the extensively phenotyped siege survivors were collected and processed (blood plasma, blood serum, and flash-frozen PBMC); serum and urine were used for laboratory tests.We believe that data obtained from this unique collection of biospecimens can elucidate the mechanisms of healthy aging and emphasize the importance of reproductive health, counseling, and monitoring among people with eating disorders.

Canine tumors are valuable comparative oncology models. This research was designed to create a sustainable biobank of canine mammary tumors for breast cancer research. The aim was to provide a well-characterized sample cohort for specimen sharing, data mining, and long-term research aims. Canine mammary tumors are most frequently managed at a local veterinary clinic or hospital. We adopted a biobank framework based on a large number of participating veterinary hospitals and clinics acting as collection centers that were serviced by a centralized storage facility. Recruitment was targeted at rural veterinary clinics. A tailored, stable collection kit (DogMATIC) was designed that was used by veterinarians in remote or rural locations to collect both fresh and fixed tissue for submission to the biobank. To validate this methodology the kit design, collection rate, and sample quality were analyzed. The Australian Veterinary Cancer Biobank was established as a network of 47 veterinary clinics and three veterinary pathology laboratories spanning over 200,000 km2. In the first 12 months, 30 canine mammary tumor cases were submitted via the DogMATIC kit. Pure intact RNA was isolated in over 80% of samples with an average yield of 14.49 μg. A large network biobank, utilizing off-site collection with the DogMATIC kit, was successfully coordinated. The creation of the Australian Veterinary Cancer Biobank has established a long-term, sustainable, comparative oncology research resource in Australia. There are broader implications for biobanking with this very different form of collection and banking.

INTRODUCTION Biobanking refers to the infrastructure, policies and practices involved in collecting, processing, storing and disseminating biological samples. Biospecimen methods research to support biobanking through evidence-based practices is now recognized as critical to the success of biobanking and translational research. SOURCES OF DATA Data concerning biospecimen research have appeared in the literature for many years, primarily in journals and textbooks focused on clinical chemistry, epidemiology and pathology. Recently, new efforts have been initiated to support the development of evidence-based biobanking practices. AREAS OF AGREEMENT Generally, researchers who are engaged in studies involving biospecimen collection are aware of the effects of pre-analytical variables on their downstream analyses, and they normally take steps to control those variables to publish reproducible results. Knowledge of such biospecimen research data is often unknown in the clinical setting unless the researchers are engaged in a project requiring strict protocols. AREAS OF CONTROVERSY There is broad agreement of the need to develop evidence-based practices to achieve consistent quality for biospecimens and data. However, due to inconsistencies in the literature, there is some disagreement on whether biospecimens need to be collected according to a 'platinum' standard or local biobank standards for collecting samples as 'fit-for-purpose' will be sufficient. GROWING POINTS New and expanded efforts, on an international basis where possible, need to be developed to better harmonize biospecimen management practices. AREAS TIMELY FOR DEVELOPING RESEARCH Additional biospecimen methods research leading to the development of evidence-based practices is critical to translational research and personalized medicine.

The Genotype-Tissue Expression (GTEx) project, sponsored by the NIH Common Fund, was established to study the correlation between human genetic variation and tissue-specific gene expression in non-diseased individuals. A significant challenge was the collection of high-quality biospecimens for extensive genomic analyses. Here we describe how a successful infrastructure for biospecimen procurement was developed and implemented by multiple research partners to support the prospective collection, annotation, and distribution of blood, tissues, and cell lines for the GTEx project. Other research projects can follow this model and form beneficial partnerships with rapid autopsy and organ procurement organizations to collect high quality biospecimens and associated clinical data for genomic studies. Biospecimens, clinical and genomic data, and Standard Operating Procedures guiding biospecimen collection for the GTEx project are available to the research community. This work was supported by the National Institutes of Health (HHSN261200800001E (Leidos Prime contract with NCI); 10XS170 (NDRI), 10XS171 (Roswell Park Cancer Institute), 10X172 (Science Care Inc.), 12ST1039 (IDOX); 10ST1035 (Van Andel Institute); HHSN268201000029C (Broad Institute); and R01 DA006227-17 (U Miami Brain Bank).

Identifying a suitable course of immunotherapy treatment for a given patient as well as monitoring treatment response is heavily reliant on biomarkers detected and quantified in blood and tissue biospecimens. Suboptimal or variable biospecimen collection, processing, and storage practices have the potential to alter clinically relevant biomarkers, including those used in cancer immunotherapy. In the present review, we summarize effects reported for immunologically relevant biomarkers and highlight preanalytical factors associated with specific analytical platforms and assays used to predict and gauge immunotherapy response. Given that many of the effects introduced by preanalytical variability are gene-, transcript-, and protein-specific, biospecimen practices should be standardized and validated for each biomarker and assay to ensure accurate results and facilitate clinical implementation of newly identified immunotherapy approaches.

The 2010 Deepwater Horizon (DWH) explosion in the Gulf of Mexico led to the largest ever marine oil spill by volume. The GuLF STUDY is investigating possible adverse human health effects associated with oil spill activities. One objective of the study was to utilize biological specimens from study participants to examine spill-related adverse health effects. This study describes the methods for collecting, processing, shipping, and storing specimens during the enrollment phase of the study. GuLF STUDY participants living in Gulf States (Alabama, Florida, Louisiana, Mississippi, and eastern Texas) were eligible to complete a home visit at enrollment, one to three years after the DWH explosion. During this visit, blood, urine, toenail and hair clippings, and house dust samples were collected. Specimens were shipped overnight to a central processing laboratory in containers with cold and ambient temperature compartments. Most blood and urine specimens were then aliquoted and stored in liquid nitrogen vapor or at -80°C, with some samples stored at -20°C. A total of 11,193 participants completed a home visit, and over 99% provided at least one biospecimen. Most participants provided blood (93%), urine (99%), and toenail clippings (89%), and 40% provided hair. Nearly all participants (95%) provided house-dust samples. Most samples were received by the laboratory one (58%) or two (25%) days after collection. These biospecimens enable investigation of a range of biomarkers of spill-related adverse health effects, and possibly some biomarkers of spill-related exposures. The biospecimen collection, handling, and storage protocols were designed to maximize current and future scientific value within logistical and budgetary constraints and might serve as a template for future studies conducted in similar time-critical and geographically dispersed settings.

The value of molecular profiled human tissue lies in its potential to improve the efficiency of drug discovery and development. The sequencing and profiling of human biospecimens across multiple omics dimensions provides layers of molecular information that can be used to enhance our knowledge of disease mechanisms to identify and prioritize novel drug targets and provide supportive biological evidence to support a therapeutic hypothesis. It is critical to control pre-analytical variables because the reproducibility and accuracy of molecular data generated by high-throughput technologies is dependent upon biospecimen quality. The scientific knowledge and technology developments gained in tissue banking research are transforming biospecimen collection and biostorage practices. These tissue banking advancements will improve specimen quality and utilization and, at the same time, reduce biobanking costs. Furthermore, well-annotated, high quality biospecimens will provide reliable, consistent gene expression data for target validation for drug discovery. Challenges in understanding the molecular signatures of biospecimens follow the challenges of human tissue acquisition. Sequencing and profiling high-throughput technologies generate heterogeneous, complex data sets that require sophisticated informatics tools for data storage and analysis. As tissue banking and informatics technologies improve and we gain deeper knowledge of the human genome and its functionality, we will see biomarker identification and target therapies brought about by the research performed on high quality biospecimens.

Objectives. We elicited perspectives of rural Latino farmworkers and non-farmworkers about their participation in a community-based participatory pesticides exposure study in which they provided multiple biospecimens. Methods. Between March and April 2012, we conducted semistructured, one-on-one interviews with 39 rural Latino farmworkers and non-farmworkers in Washington State (n = 39). Nineteen open-ended interview questions aimed to elicit participants’ attitudes toward, expectations and experiences of biospecimen collection for research, and willingness to participate in future biomedical research studies. We reviewed and coded transcriptions using qualitative principles of grounded theory in which concepts were identified and themes derived from interview data. Results. We grouped themes into 3 major categories: (1) motivation to participate, (2) challenges of participation, and (3) perceived rewards of participation. Many participants were motivated by the perceived importance of the study topic and a desire to acquire and contribute to new knowledge. Respondents said that the benefits of participation outweighed the challenges, and many expressed satisfaction to be able to contribute to research that would benefit future generations. Conclusions. Our findings supported the use of community-based participatory research to engage minorities as participants and invested parties in such studies.