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Background: We aim to present the development and the initial results of the Golestan Cancer Biobank (GoCB), in a low resource setting in northern Iran. Methods: The GoCB protocol and its standard operation procedures (SOP) were developed according to internationally accepted standards and protocols with some modifications considering the limited resources in our setting. The main biological samples collected by the GoCB include blood sample, urine sample, fresh endoscopy tissue sample, fresh surgical tissue sample and formalin fixed paraffin embedded (FFPE) tissue sample. The GoCB collects patients' demographic data, tumor characteristics as well as data on risk factors. We developed a specific GoCB software for management of patient data and biological sample information. The GoCB dataset is annually linked with the Golestan cancer registry dataset to add complementary data (e.g., survival data). Results: The GoCB started collection of data and biological samples in December 2016. By November 2020, a total number of 1217 cancer patients participated in the GoCB. The majority of the GoCB participants (n = 942, 77) were those with gastrointestinal and breast cancers. Data on risk factors were successfully collected in 684 (56.2) of the participants. Overall, 3563 samples were collected from the GoCB participants and 730 samples were used in 7 national and international research projects. Conclusion: We considered specific strategies to overcome major limitations, especially budget shortage, in the development and maintenance of a cancer-specific biological repositories in our setting. The GoCB may be considered as a model for the development of biobank in low- and middle-income countries (LMICs). © 2021 Academy of Medical Sciences of I.R. Iran. All rights reserved.

Biobank, defined as a functional unit for facilitating and improving research by storing biospecimen and their accompanying data, is a key resource for advancement in life science. The history of biobanking goes back to the time of archiving pathology samples. Nowadays, biobanks have considerably improved and are classified into two categories: diseased-oriented and population-based biobanks. UK biobank as a population-based biobank with about half a million samples, Biobank Graz as one of the largest biobanks in terms of sample size, and The International Agency for Research on Cancer biobank as a specialized the World Health Organization cancer agency are few examples of successful biobanks worldwide. The present review provides a history of biobanking, and after presenting different biobanks, we discuss in detail the challenges in the field of biobanking and its future, as well. In the end, ICR biobank, as the first cancer biobank in Iran established in 1998, is thoroughly described.

Biobanking has become an indispensable tool for translational research and health innovations. While the field of biobanking has progressed and evolved globally, biobanking in developing Association of Southeast Asian Nations (ASEAN) countries such as the Philippines remains underrepresented because of several challenges often encountered in these low- and middle-income countries. Recently, the Philippine government has undertaken enormous efforts to advancing research and development in the country, and one of the current research pursuits is the establishment of biobanks, with the hope of attaining more discoveries and innovations in the future. Given that cancer remains a leading cause of death in the Philippines, the Philippine government supported the establishment of a cancer biobank at the Philippine General Hospital (PGH). In this study, we present a specific use case of biobanking activity at the PGH Biobank, to build a cohort of biospecimens from Filipino patients with breast, endometrial, and ovarian cancer. This initiative is part of a biomonitoring study (1) to assess environmental exposures and possible risk factors in the Philippine population and (2) to develop a system of culturing human cells from Filipino patients for subsequent in vitro studies. We discuss issues faced and the solutions developed during the implementation of the biobank. Strong research collaboration, a funding source, basic infrastructure, and appropriate technology helped initiate this pilot biobank in the Philippines. Overall, the experiences of establishing the PGH Biobank may help other institutions in low-resource countries to set up cancer biobanks.

BACKGROUND: Genomic analysis may reveal both primary and secondary findings with direct relevance to the health of probands’ biological relatives. Researchers question their obligations to return findings not only to participants but also to family members. Given the social value of privacy protection, should researchers offer a proband’s results to family members, including after the proband’s death? METHODS: Preferences were elicited using interviews and a survey. Respondents included probands from two pancreatic cancer research resources, plus biological and non-biological family members. Hypothetical scenarios based on actual research findings from the two cancer research resources were presented; participants were asked return of results preferences and justifications. Interview transcripts were coded and analyzed; survey data were analyzed descriptively. RESULTS: 51 individuals (17 probands, 21 biological relatives, 13 spouses/partners) were interviewed. Subsequently, a mailed survey was returned by 464 probands, 1,040 biological family members, and 399 spouses/partners. This analysis highlights the interviews, augmented by survey findings. Probands and family members attribute great predictive power and life-saving potential to genomic information. A majority hold that a proband’s genomic results relevant to family members’ health ought to be offered. While informants endorse each individual’s choice whether to learn results, most express a strong moral responsibility to know and to share, particularly with the younger generation. Most have few concerns about sharing genetic information within the family; rather, their concerns focus on the health consequences of not sharing. CONCLUSIONS: Although additional studies in diverse populations are needed, policies governing return of genomic results should consider how families understand genomic data, how they value confidentiality within the family, and whether they endorse an ethics of sharing. A focus on respect for individual privacy—without attention to how the broad social and cultural context shapes preferences within families—cannot be the sole foundation of policy.

Objectives Inadequate research biospecimen quality may adversely impact research translation to clinical practice. Despite the development and endorsement of external quality assurance (QA) programs and biospecimen quality reporting tools, there has been little examination of relevant biobank practices. Design and methods An online survey was designed to describe the use and communication of QA and quality control (QC) measures within an Australian cancer biobank cohort (n=21), classified according to access policy. Survey questions examined the development and maintenance of Standard Operating Procedures (SOPs), other specific QA and biospecimen QC activities, and communication of biospecimen QC results to researchers. Results Over three quarters of biobanks utilised regularly-reviewed, best-practice-referenced SOPs, and most biobanks undertook at least one QC activity. Whereas all open-access biobanks (n=11) utilised SOPs and undertook at least one QC activity, these practices were significantly less frequent in restricted-access biobanks (n=10). There were overall low rates of recording the SPREC code, with increased but incomplete recording of Tier 1 BRISQ data. Open-access biobanks were significantly more likely to provide biospecimen QC results to researchers, and to report receiving requests for QC results or additional sample data. Conclusions Improved resourcing and education may be required to boost current levels of QA and QC activities and reporting by cancer biobanks.

Interscience Molecular Oncology Laboratory, University of Ioannina Cancer Biobank Center, Ioannina, Greece Division of Brain Sciences, Imperial College, London, UK Laboratory of Cancer Genetics & Translational Oncology, Oncology Department, S. Croce University Hospital, Cuneo, Italy Dundee Cancer Center, University of Dundee, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK *Author for correspondence: Tel.: +44 1438 67834; tcrook@dundee.ac.uk Background: why do we need a blood test for metastatic melanoma? Malignant melanoma is an aggressive skin cancer arising from the melanocytes. For many patients, the appearance of metastatic disease occurs (sometimes years) after apparently curative surgical excision of primary lesions. In others, presentation occurs with metastatic disease. In either case, once the disease becomes unresectable and management becomes entirely medical, longterm survival is unusual. For many years, the medical management of metastatic melanoma was largely ineffective and the prognosis of advanced disease was accordingly poor, with survival after diagnosis of visceral and/or CNS metastases typically being only a few months. The reasons for this dismal situation were several-fold

The US Department of Health and Human Services addresses clear communication in the informed consent process as part of the Notice of Proposed Rulemaking for revisions to the Common Rule. However, prior research has shown that participants may not fully comprehend research studies despite completion of an informed consent process. Our main goal was to provide plain language information about donation processes to a cancer biobank to supplement an informed consent form. We developed and conducted cognitive testing with supplemental brochures that clearly communicated information about three different models for consent (notice, broad and study-specific) to future use of biospecimens. During the brochure development process, we conducted qualitative, semi-structured, individual, in-person cognitive interviews among 14 women to examine participants' perceptions of the brochures. Each participant provided feedback regarding the understandability, graphics and layout, and cultural appropriateness of the brochures. Our findings demonstrate that these methods may be used to tailor consent form brochures, such as the ones developed here, to other populations. This study therefore adds to our understanding of how best to present content to help women from two different racial groups make informed decisions about participation in a cancer biobank.

There are concerns that a substantial proportion of published research data is not reproducible, which may partially explain the frequent failure to translate pre-clinical results to clinical care. High-quality cancer biospecimens are needed for robust, reproducible research findings, with most researchers obtaining these specimens from cancer biobanks or tumour banks. This review provides an overview of the types of quality control (QC) activities conducted within cancer biobanks that pertain to biospecimen quality and of biospecimen quality reporting tools, including SPREC and BRISQ. We examine how QC assay results and other biospecimen data are communicated from biobanks to researchers, and whether these activities lead to improved biospecimen quality reporting within the literature and/or to improved research outcomes. We also discuss operational factors that limit QC activities within biobanks and evidence gaps requiring further research. In summary, whereas the provision of quality biospecimens is a common aim of cancer biobanks, QC activities remain underreported and are rarely discussed in the literature, compared with other aspects of biobank operations. Further research is required to determine how biobanks can most efficiently optimise biospecimen quality, and how communication between biobanks and researchers can be improved.

Although rarely acknowledged, a successful biobank is highly dependent on the support of the health professionals who assist the biobank in all aspects of its activities. In many cases, the lack of health professional support can be a limiting factor in the biobanking process of collecting and processing high-quality biospecimens. The aim of this study was to determine the attitudes of health professionals towards cancer biobanking. Using a 5-point Likert scale questionnaire, important aspects of biobanking, including accrual, quality, knowledge, responsiveness, impact, access, trust, governance and accreditation, were investigated. In total, 95 of 124 health and medical practitioners who were approached participated in this study (77% response rate). Health professionals in general supported the aims of biobanking with 56% of participants showing willingness to create a biobank and recruit donors (accrual), 85% understanding the importance in the storage and distribution of biospecimens (quality), 88% having an appreciation for the role of a biobank in furthering cancer research (knowledge), 70% showing awareness of the use of biospecimens in future research initiatives (responsiveness) and 73% demonstrating support for a biobank with proper control, authority and credibility measures in place (governance and accreditation). Overall, provided that proper information about the activities of the biobank and researcher access was transparent, health professionals were very willing to support cancer biobanking. These findings may assist in developing strategies for the establishment and maintenance of biobanks and aid the implementation of more effective policies and procedures to embed biobanking into routine hospital practices.

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.

In 2011, Watson and Barnes proposed a schema for classifying biobanks into 3 groups (mono-, oligo-, and poly-user), primarily based upon biospecimen access policies. We used results from a recent comprehensive survey of cancer biobanks in New South Wales, Australia to assess the applicability of this biobank classification schema in an Australian setting. Cancer biobanks were identified using publically available data, and by consulting with research managers. A comprehensive survey was developed and administered through a face-to-face setting. Data were analyzed using Microsoft Excel™ 2010 and IBM SPSS Statistics™ version 21.0. The cancer biobank cohort (n=23) represented 5 mono-user biobanks, 7 oligo-user biobanks, and 11 poly-user biobanks, and was analyzed as two groups (mono-/oligo- versus poly-user biobanks). Poly-user biobanks employed significantly more full-time equivalent staff, and were significantly more likely to have a website, share staff between biobanks, access governance support, utilize quality control measures, be aware of biobanking best practice documents, and offer staff training. Mono-/oligo-user biobanks were significantly more likely to seek advice from other biobanks. Our results further delineate a biobank classification system that is primarily based on access policy, and demonstrate its relevance in an Australian setting.

There is a growing interest in integrating biomaterial repositories into larger infrastructures in order to meet research demands. However, even for a single hospital or institute, where both population-based and multiple disease-based biobanks have existed for a long time, the integration of existing separate biobanks into a virtual cancer biobank is still challenging. The guidelines and procedures for biobanking are varied and not universally enforced or followed in separate biobanks. Within the last 2 years, we initiated a project to establish a centralized biobank facility in a common storage environment. Analyzing the challenges and interests of stakeholders for the biobanks, a working group comprised of representatives from the central and separate banks, ethic committees, and research administration offices reached an agreement to implement a central facility by following the ISBER best practices for biobanking, and including regular project reviews by the ethical and scientific boards. Furthermore, by implementing a modified minimum information system with biobank data sharing, a network based intra-hospital virtual cancer bank was established to facilitate sharing information of samples held by separate banks. Meanwhile, this virtual biobank network, which has integrated patient information from hospital health care systems, will gradually integrate follow-up information from the cancer registry office and data from epidemiology studies, providing controlled access for sample providers and resource users. In the future, this infrastructure designed for a single hospital may be helpful for building a broader virtual network for data and specimen exchanges.

Motivation: The probability of effective treatment of cancer with a targeted therapeutic can be improved for patients with defined genotypes containing actionable mutations. To this end, many human cancer biobanks are integrating more tightly with genomic sequencing facilities and with those creating and maintaining patient-derived xenografts (PDX) and cell lines to provide renewable resources for translational research. Results: To support the complex data management needs and workflows of several such biobanks, we developed Acquire. It is a robust, secure, web-based, database-backed open-source system that supports all major needs of a modern cancer biobank. Its modules allow for i) up-to-the-minute ‘scoreboard’ and graphical reporting of collections; ii) end user roles and permissions; iii) specimen inventory through caTissue Suite; iv) shipping forms for distribution of specimens to pathology, genomic analysis and PDX/cell line creation facilities; v) robust ad hoc querying; vi) molecular and cellular quality control metrics to track specimens’ progress and quality; vii) public researcher request; viii) resource allocation committee distribution request review and oversight and ix) linkage to available derivatives of specimen. Availability and Implementation: Acquire implements standard controlled vocabularies, ontologies and objects from the NCI, CDISC and others. Here we describe the functionality of the system, its technological stack and the processes it supports. A test version Acquire is available at https://tcrbacquire-stg.research.bcm.edu; software is available in https://github.com/BCM-DLDCC/Acquire; and UML models, data and workflow diagrams, behavioral specifications and other documents are available at https://github.com/BCM-DLDCC/Acquire/tree/master/supplementaryMaterials. Contact: becnel@bcm.edu

Biobank data and samples frequently endure beyond the life of the individual who provided the sample; this is particularly true for biorepositories that archive data and samples from cancer patients. Those data and samples may be used for research, including after the death of the individual. When the research produces genetic research results (a term used here to include incidental findings and individual research results) that have potential health or reproductive importance for the individual who provided the sample, the results may also have importance for blood relatives. This raises the question of whether the research results should be shared with relatives, at their request or at the initiative of the researchers. The issues are complex even when the research participant is alive, but are particularly challenging after the death of the individual whose data and sample are archived, as the individual may not have been asked their preferences about sharing with family, including after death. Even if the individual’s preferences on sharing have been elicited, investigators and biobank directors may be concerned about withholding genetic research results from relatives that are of potential health significance.

// Victoria Bingham 2 , Leanne McIlreavey 2 , Christine Greene 1,3 , Edwina O’Doherty 1,3 , Rebecca Clarke 2 , Stephanie Craig 2 , Manuel Salto-Tellez 2 , Stephen McQuaid 1,2,3 Claire Lewis 1,2 and Jacqueline James 1,2,3 1 Northern Ireland Biobank, Centre for Cancer Research and Cell Biology, Queen’s University, Belfast, UK 2 Molecular Pathology Programme, Centre for Cancer Research and Cell Biology, Queen’s University, Belfast, UK 3 Tissue Pathology, Belfast Health and Social Care Trust, Belfast City Hospital, Belfast, UK Correspondence to: Stephen McQuaid, email: // Keywords : mRNA; FFPE; in situ hybridization; Integrity; Pathology Section Received : July 27, 2017 Accepted : October 05, 2017 Published : October 16, 2017 Abstract Immunohistochemistry remains the overwhelming technique of choice for test biomarker evaluation in both clinical or research settings when using formalin-fixed, paraffin embedded tissue sections. However, validations can be complex with significant issues about specificity, sensitivity and reproducibility. The vast array of commercially available antibodies from many vendors may also lead to non-standard approaches which are difficult to cross-reference. In contrast mRNA detection, by in situ hybridization (ISH) with sequence specific probes, offers a realistic alternative, with less validation steps and more stringent and reproducible assessment criteria. In the present study mRNA ISH was evaluated in prospectively and retrospectively collected FFPE samples within a cancer biobank setting. Three positive control probes, POLR2A, PPIB and UBC were applied to FFPE sections from a range of tumour types in FFPE whole-face (prospective collection) or TMA (retrospective collection) formats and evaluated semi-quantitatively and by image analysis. Results indicate that mRNA can be robustly evaluated by ISH in prospectively and retrospectively collected tissue samples. Furthermore, for 2 important test biomarkers, PD-L1 and c-MET, we show that mRNA ISH is a technology that can be applied with confidence in the majority of tissue samples because there are quantifiable levels of control probes indicating overall mRNA integrity.

Research studies aimed at advancing cancer prevention, diagnosis, and treatment depend on a number of key resources, including a ready supply of high-quality annotated biospecimens from diverse ethnic populations that can be used to test new drugs, assess the validity of prognostic biomarkers, and develop tailor-made therapies. In November 2011, KHCCBIO was established at the King Hussein Cancer Center (KHCC) with the support of Seventh Framework Programme (FP7) funding from the European Union (khccbio.khcc.jo). KHCCBIO was developed for the purpose of achieving an ISO accredited cancer biobank through the collection, processing, and preservation of high-quality, clinically annotated biospecimens from consenting cancer patients, making it the first cancer biobank of its kind in Jordan. The establishment of a state-of-the-art, standardized biospecimen repository of matched normal and lung tumor tissue, in addition to blood components such as serum, plasma, and white blood cells, was achieved through the support and experience of its European partners, Trinity College Dublin, Biostór Ireland, and accelopment AG. To date, KHCCBIO along with its partners, have worked closely in establishing an ISO Quality Management System (QMS) under which the biobank will operate. A Quality Policy Manual, Validation, and Training plan have been developed in addition to the development of standard operating procedures (SOPs) for consenting policies on ethical issues, data privacy, confidentiality, and biobanking bylaws. SOPs have also been drafted according to best international practices and implemented for the donation, procurement, processing, testing, preservation, storage, and distribution of tissues and blood samples from lung cancer patients, which will form the basis for the procurement of other cancer types. KHCCBIO will be the first ISO accredited cancer biobank from a diverse ethnic Middle Eastern and North African population. It will provide a unique and valuable resource of high-quality human biospecimens and anonymized clinicopathological data to the cancer research communities world-wide.

Mammography is the predominant screening method for early detection of breast cancer, but has limitations and could be rendered more accurate by combination with a blood-based biomarker profile. Circulating microRNAs (miRNAs) are increasingly recognized as strong biomarkers, and we previously developed a 9-miRNA profile using serum and LNA-based qPCR that effectively stratified patients with early stage breast cancer vs. healthy women. To further develop the test into routine clinical practice, we collected serum of women examined by clinical mammography (N = 197) according to standard operational procedures (SOPs) of the Danish Cancer Biobank. The performance of the circulating 9-miRNA profile was analyzed in 116 of these women, including 36 with breast cancer (aged 50-74), following a standardized protocol that mimicked a routine clinical set-up. We confirmed that the profile is significantly different between women with breast cancer and controls (p-value

Identification of diagnostic markers for early detection and development of novel and therapeutic agents for effective patient management are the main motivation for cancer research. Biological specimens from large cohort and case-control studies which are crucial in providing successful research outcomes are often the limiting factor that hinders research efforts, especially in developing countries. Therefore, the Malaysian Oral Cancer Database and Tissue Bank System (MOCDTBS) were established to systematically collect large number of samples with comprehensive sociodemographic, clinicopathological, management strategies, quality of life and associated patient follow-up data to facilitate oral cancer research in Malaysia. The MOCDTBS also promotes sharing among researchers and the development of a multidisciplinary research team. The following article aims to describe the process of setting-up and managing the MOCDTBS.

Brazil and Latin America will face a cancer epidemic in the coming years. Efforts towards cancer prevention, early detection and treatment must be associated with active research that helps understanding the geographical variations of this disease. The creation of cancer-oriented biobanks should be part of this strategy. This article outlines the challenges of establishing a cancer-oriented biobank at the A. C. Camargo Center, a private, non-profit institution located in Sao Paulo, Brazil. We analyze important issues related to the day-to-day operations of the biobank within an institutional and national context, as well as the lessons learned over the years. It is hoped that the information contained in this paper will be useful for the development of other biobanks in Brazil and other countries in Latin America.

King Hussein Cancer (KHCC) is a specialized cancer center that treats both adult and pediatric cancer patients from Jordan and the neighboring countries. KHCC is acknowledged as a leader in cancer treatment in the Middle East and its vision is to maintain its leading position in cancer therapy and research. Hence, KHCC embarked on establishing the first ISO compliant cancer biobank (KHCCBIO) in Jordan.

Human papillomavirus (HPV) 33, a member of the HPV16-related alpha-9 species group, is found in approximately 5% of cervical cancers worldwide. The current study aimed to characterize the genetic diversity of HPV33 and to explore the association of HPV33 variants with the risk for cervical cancer. Taking advantage of the International Agency for Research on Cancer biobank, we sequenced the entire E6 and E7 open reading frames of 213 HPV33-positive cervical samples from 30 countries. We identified 28 HPV33 variants that formed 5 phylogenetic groups: the previously identified A1, A2, and B (sub)lineages and the novel A3 and C (sub)lineages. The A1 sublineage was strongly over-represented in cervical cases compared to controls in both Africa and Europe. In conclusion, we provide a classification system for HPV33 variants based on the sequence of E6 and E7 and suggest that the association of HPV33 with cervical cancer may differ by variant (sub)lineage.

Background Efforts to improve patients’ understanding of their own medical treatments or research in which they are involved are progressing, especially with regard to informed consent procedures. We aimed to design a multisource informed consent procedure that is easily adaptable to both clinical and research applications, and to evaluate its effectiveness in terms of understanding and awareness, even in less educated patients. Methods We designed a multisource informed consent procedure for patients’ enrolment in a Cancer Institute Biobank (CRO-Biobank). From October 2009 to July 2011, a total of 550 cancer patients admitted to the Centro di Riferimento Oncologico IRCCS Aviano, who agreed to contribute to its biobank, were consecutively enrolled. Participants were asked to answer a self-administered questionnaire aim at exploring their understanding of biobanks and their needs for information on this topic, before and after study participation. Chi-square tests were performed on the questionnaire answers, according to gender or education. Results Of the 430 patients who returned the questionnaire, only 36.5% knew what a biobank was before participating in the study. Patients with less formal education were less informed by some sources (the Internet, newspapers, magazines, and our Institute). The final assessment test, taken after the multisource informed consent procedure, showed more than 95% correct answers. The information received was judged to be very or fairly understandable in almost all cases. More than 95% of patients were aware of participating in a biobank project, and gave helping cancer research (67.5%), moral obligation, and supporting cancer care as main reasons for their involvement. Conclusions Our multisource informed consent information system allowed a high rate of understanding and awareness of study participation, even among less-educated participants, and could be an effective and easy-to-apply model for others to consider to contribute to a well-informed decision making process in several fields, from clinical practice to research. Further studies are needed to explore the effects on the study comprehension by each source of information, and by other sources suggested by participants in the questionnaire.

In recent years there has been an increased interest in using biorepositories in cancer epidemiology to investigate etiological factors as well as define biomarkers of early detection, treatment and prognosis. Advancing cancer research through biospecimen science requires a high focus on quality (1,2). When introducing molecular epidemiology in the 1980s, the expectation was that it would help overcome some major limitations of epidemiology and facilitate cancer prevention. This first generation of markers has contributed to the understanding of risk and susceptibility related largely to genotoxic carcinogens. Today a number of new and promising biomarkers are becoming available for epidemiological studies, thanks to the development of high-throughput technologies and theoretical advances in biology (3). One major challenge in biobank-based research is the access to large series of high quality biospecimens and data on disease outcome and confounding variables. The Janus Serum Bank was established in the early 1970s with the aim of searching in the premorbid sera for chemical, biochemical, immunological, or other changes that might indicate cancer development at early stages, or be indicative of increased risk of cancer (4-6). It is a population-based biobank with blood serum samples from 317 000 individuals from 17 counties in Norway. The main part of the collection derives from screening health examination participants (90%) and the remaining 10% is from Red Cross blood donors in Oslo. The Norwegian Cancer Society financed the operation of the bank up to 2004, since then it has been fully integrated within the Cancer Registry of Norway. This integration optimizes the use of the biobank by providing the unique opportunity to contribute with biological specimens and high quality clinical data from cancer patients. The development, sample collection, quality assurance and methodological considerations in Janus projects are described elsewhere (7). In the present communication we want to describe the experiences from 35 years of operation of a prospective cancer biobank.

The University of Pavia (Italy) and the IRCCS Fondazione Salvatore Maugeri hospital in Pavia have recently started an information technology initiative to support clinical research in oncology called ONCO-i2b2. This project aims at supporting translational research in oncology and exploits the software solutions implemented by the Informatics for Integrating Biology and the Bed-side (i2b2) research center. The ONCO-i2b2 software is designed to integrate the i2b2 infrastructure with the hospital information system, with the pathology unit and with a cancer biobank that manages both plasma and cancer tissue samples. Exploiting the medical concepts related to each patient, we have developed a novel data mining procedure that allows researchers to easily identify patients similar to those found with the i2b2 query tool, so as to increase the number of patients, compared to the patient set directly retrieved by the query. This allows physicians to obtain additional information that can support new insights in the study of tumors.

Background: Biobanks serve as essential resources for genetic and public health research. Despite their potential utility in elucidation of cancer susceptibility and development of novel cancer surveillance, diagnostic, and therapeutic approaches, most genomic research studies rely on samples with limited ethnic diversity. There is also a suggestion that disparities in participation in cancer biospecimen research have already translated into fewer efficacious treatments for under-represented groups. Inclusion of more diverse populations in biospecimen banks could ultimately contribute to a reduction in disparities in cancer morbidity and mortality that adversely impact U.S. minority groups. Research Objectives: We hypothesized that a deliberative group consent process related to cancer biobank donation would increase African American community engagement, foster an open dialogue between community members and researchers present at the discussion, allow participants to have their concerns addressed, and improve community members' knowledge and attitudes, leading to donation of biospecimens. Methods: We employed a two-stage study design. During the first stage, the Johns Hopkins Center to Reduce Cancer Disparities (JHCRCD) used a Community Based Participatory Research (CBPR) framework that explored the knowledge and attitudes of African American adults in Maryland regarding participation in a cancer biospecimen repository. We completed eight focus groups with primarily African American communities in Baltimore City and Prince George's County. Results: Stage-one results indicate that African American residents of Baltimore and Prince Georges County face limited understanding and lack of awareness in genetics and genomics. Our baseline analyses revealed limited community knowledge about biobanking and initial reluctance to donate biospecimen samples. Some participants expressed distrust in the research enterprise. After some discussion, however, participants were able to identify personal, familial, and societal benefits to participation. Moreover, focus group participants identified a number of strategies to overcome concerns and to enhance participation, including mechanisms for enhanced communication with researchers and suggestions related to building the biobank's community presence. In spite of initial concerns expressed during the focus groups, most participants stated their willingness to donate a specimen in the future if their concerns were properly addressed. Conclusions and Next Steps: Future reductions in cancer morbidity and mortality among minority groups will depend upon increasing the diversity of populations donating samples. The proposed project will provide data to support early communication and transparency to build community trust from the earliest stages of the cancer research process. Stage two of the project will commence in September of 2014. During the second stage, we propose: (a) To examine the impact of a deliberative group consent process on community members' attitudes and knowledge related to donating specimens to a pilot cancer biobank; (b) To identify participant characteristics (including genetic literacy, educational status, gender, personal cancer history, family cancer history, attitudes, and knowledge) that predict actual donation to a pilot cancer biobank; and (c) To create a pilot (small scale) cancer biobank with samples from the African American community for use in future genomic and epigenomic studies Citation Format: Fahcina P. Lawson, Oluwasina Folawiyo, Francesca Pirini, Blanca L. Valle, David Sidransky, Jean Ford, Lori Erby, Rafael Guerrero-Preston. Enrolling African Americans into a cancer-related biobank. [abstract]. In: Proceedings of the Seventh AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 9-12, 2014; San Antonio, TX. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2015;24(10 Suppl):Abstract nr A28.

One critical issue in cancer research biobanking is improving representation of America's minority and medically underserved populations. Rural populations often suffer disparities related to poverty and healthcare access, limiting their participation in cancer research. We report a case series of newly diagnosed cancer patients at Eastern Maine Medical Center (EMMC), a rural comprehensive medical center. Of 85 eligible cases, 83 (98%) consented to participate in biobanking research; 2 years later, survivors (87%) consented to 2 additional requests. We used NCI/ISBER Best Practices to create biobank infrastructure after approval by EMMC IRB and OHP HRPO. Informed consent forms were at Flesch-Kincaid 8th Grade reading level, and supplemented by NCI educational brochures. Cases lived 50-150 miles from EMMC. Of 108 candidates, 83 eligible cases (49 lung cancer; 21 breast cancer; 13 other cancers) consented to questionnaires and donation of blood and/or tissue. Of the remaining 23 cases, 2 declined; cancer was not confirmed in 12; 4 died, and 7 were ineligible. Within 2 years, 14 cases died. Of those alive, 60/69 (87%) were re-contacted and consented to additional data collection, and transfer of biospecimens to NCI's biorepository. Most cases exhibited co-morbidities with 1-3 chronic diseases (mostly cardiovascular), prior cancer history and long-term tobacco and/or alcohol consumption. Nearly 90% reported 1+ relative with cancer, while 69%, reported 1+ prior cancers. Anecdotally, willingness to consent was based on altruistic hopes that research would generate knowledge to reduce cancer incidence. In summary, cancer patients from disadvantaged rural communities will consent to participate in biobank research. Citation Format: Janet M. Hock, Deborah G. Morrison, Christopher C. Farah. Informed consent for cancer biobank research: Case series of patients with cancer disparities in rural Maine. [abstract]. In: Proceedings of the Fifth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2012 Oct 27-30; San Diego, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2012;21(10 Suppl):Abstract nr A30.