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Documents sent to hospitals to collect tumor samples for the Cancer Prevention Study-II Nutrition Cohort Colorectal Tissue Repository.

Background: To better understand colorectal cancer etiology and prognosis, archived surgical tissues were collected from Cancer Prevention Study II (CPS-II) Nutrition Cohort participants who were diagnosed with colorectal cancer. Herein, the methodology for this collection is described to help inform other efforts to collect tissues.Methods: The main components to accruing tissue were: (i) obtaining consent from participants or next-of-kin; (ii) contacting hospitals to request materials; and (iii) pathology review and laboratory processing.Results: In CPS-II, we identified 3,643 participants diagnosed with colorectal cancer between 1992/1993 and 2009. Of these, tissue could not be sought from cases verified through state cancer registry linkage (N = 1,622), because of insufficient information on tissue location. We sought tissue from the 2,021 cases verified using medical records, and received tissue from 882. When hospitals were contacted within 10 years of diagnosis, we received 87% of tissue materials; beyond that 10-year mark, we received 32%. Compared with the 2,761 colorectal cancer cases without tissue, the 882 cases with tissue were more likely to be alive, diagnosed more recently during follow-up, and had less-advanced staged disease. Cases with and without tissues were similar with respect to age at diagnosis, smoking, body mass index, physical activity, and other epidemiologic factors.Conclusions: Some of the most important elements in forming a tissue repository included having the cases' hospital contact and surgical accession information as well as contacting patients/next-of-kin and hospitals within 10 years of surgery.Impact: This tissue repository will serve as an important resource for colorectal cancer studies.See all the articles in this CEBP Focus section, “Biomarkers, Biospecimens, and New Technologies in Molecular Epidemiology.”Cancer Epidemiol Biomarkers Prev; 23(12); 2694–702. ©2014 AACR.

Documents sent to participants or spouses to obtain informed consent for participating in the Cancer Prevention Study-II Nutrition Cohort Colorectal Tissue Repository.

The rapid pace of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; COVID-19) pandemic presents challenges to the real-time collection of population-scale data to inform near-term public health needs as well as future investigations. We established the COronavirus Pandemic Epidemiology (COPE) consortium to address this unprecedented crisis on behalf of the epidemiology research community. As a central component of this initiative, we have developed a COVID Symptom Study (previously known as the COVID Symptom Tracker) mobile application as a common data collection tool for epidemiologic cohort studies with active study participants. This mobile application collects information on risk factors, daily symptoms, and outcomes through a user-friendly interface that minimizes participant burden. Combined with our efforts within the general population, data collected from nearly 3 million participants in the United States and United Kingdom are being used to address critical needs in the emergency response, including identifying potential hot spots of disease and clinically actionable risk factors. The linkage of symptom data collected in the app with information and biospecimens already collected in epidemiology cohorts will position us to address key questions related to diet, lifestyle, environmental, and socioeconomic factors on susceptibility to COVID-19, clinical outcomes related to infection, and long-term physical, mental health, and financial sequalae. We call upon additional epidemiology cohorts to join this collective effort to strengthen our impact on the current health crisis and generate a new model for a collaborative and nimble research infrastructure that will lead to more rapid translation of our work for the betterment of public health.

BackgroundData for frontline healthcare workers (HCWs) and risk of SARS-CoV-2 infection are limited and whether personal protective equipment (PPE) mitigates this risk is unknown. We evaluated risk for COVID-19 among frontline HCWs compared to the general community and the influence of PPE.MethodsWe performed a prospective cohort study of the general community, including frontline HCWs, who reported information through the COVID Symptom Study smartphone application beginning on March 24 (United Kingdom, U.K.) and March 29 (United States, U.S.) through April 23, 2020. We used Cox proportional hazards modeling to estimate multivariate-adjusted hazard ratios (aHRs) of a positive COVID-19 test.FindingsAmong 2,035,395 community individuals and 99,795 frontline HCWs, we documented 5,545 incident reports of a positive COVID-19 test over 34,435,272 person-days. Compared with the general community, frontline HCWs had an aHR of 11·6 (95% CI: 10·9 to 12·3) for reporting a positive test. The corresponding aHR was 3·40 (95% CI: 3·37 to 3·43) using an inverse probability weighted Cox model adjusting for the likelihood of receiving a test. A symptom-based classifier of predicted COVID-19 yielded similar risk estimates. Compared with HCWs reporting adequate PPE, the aHRs for reporting a positive test were 1·46 (95% CI: 1·21 to 1·76) for those reporting PPE reuse and 1·31 (95% CI: 1·10 to 1·56) for reporting inadequate PPE. Compared with HCWs reporting adequate PPE who did not care for COVID-19 patients, HCWs caring for patients with documented COVID-19 had aHRs for a positive test of 4·83 (95% CI: 3·99 to 5·85) if they had adequate PPE, 5·06 (95% CI: 3·90 to 6·57) for reused PPE, and 5·91 (95% CI: 4·53 to 7·71) for inadequate PPE.InterpretationFrontline HCWs had a significantly increased risk of COVID-19 infection, highest among HCWs who reused PPE or had inadequate access to PPE. However, adequate supplies of PPE did not completely mitigate high-risk exposures.FundingZoe Global Ltd., Wellcome Trust, EPSRC, NIHR, UK Research and Innovation, Alzheimer’s Society, NIH, NIOSH, Massachusetts Consortium on Pathogen ReadinessRESEARCH IN CONTEXTEvidence before this studyThe prolonged course of the coronavirus disease 2019 (COVID-19) pandemic, coupled with sustained challenges supplying adequate personal protective equipment (PPE) for frontline healthcare workers (HCW), have strained global healthcare systems in an unprecedented fashion. Despite growing awareness of this problem, there are few data to inform policy makers on the risk of COVID-19 among HCWs and the impact of PPE on their disease burden. Prior reports of HCW infections are based on cross sectional data with limited individual-level information on risk factors for infection. A PubMed search for articles published between January 1, 2020 and May 5, 2020 using the terms “covid-19”, “healthcare workers”, and “personal protective equipment,” yielded no population-scale investigations exploring this topic.Added value of this studyIn a prospective study of 2,135,190 individuals, frontline HCWs may have up to a 12-fold increased risk of reporting a positive COVID-19 test. Compared with those who reported adequate availability of PPE, frontline HCWs with inadequate PPE had a 31% increase in risk. However, adequate availability of PPE did not completely reduce risk among HCWs caring for COVID-19 patients.Implications of all the available evidenceBeyond ensuring adequate availability of PPE, additional efforts to protect HCWs from COVID-19 are needed, particularly as lockdown is lifted in many regions of the world.

All states in the United States now have a well-established cancer registry. Linkage with these registries may be a cost-effective method of follow-up for cancer incidence in multistate cohort studies. However, the sensitivity of linkage with the current network of state registries for detecting incident cancer diagnoses within cohort studies is not well-documented. We examined the sensitivity of registry linkage among 39,368 men and women from 23 states who enrolled in the Cancer Prevention Study-3 cohort during 2006-2009 and had the opportunity to self-report cancer diagnoses on a questionnaire in 2011. All participants provided name and birthdate, and 94% provided a complete social security number. Of 378 cancer diagnoses between enrollment and 2010 identified through self-report and verified with medical records, 338 were also detected by linkage with the 23 state cancer registries (sensitivity of 89%, 95% confidence interval (CI): 86, 92). Sensitivity was lower for hematologic cancers (69%, 95% CI: 41, 89) and melanoma (70%, 95% CI: 57, 81). After excluding hematologic cancers and melanoma, sensitivity was 94% (95% CI: 91, 97). Our results indicate that linkage with multiple cancer registries can be a sensitive method for ascertaining incident cancers, other than hematologic cancers and melanoma, in multistate cohort studies.

Background: To better understand colorectal cancer etiology and prognosis, archived surgical tissues were collected from Cancer Prevention Study II (CPS-II) Nutrition Cohort participants who were diagnosed with colorectal cancer. Herein, the methodology for this collection is described to help inform other efforts to collect tissues. Methods: The main components to accruing tissue were: (i) obtaining consent from participants or next-of-kin; (ii) contacting hospitals to request materials; and (iii) pathology review and laboratory processing. Results: In CPS-II, we identified 3,643 participants diagnosed with colorectal cancer between 1992/1993 and 2009. Of these, tissue could not be sought from cases verified through state cancer registry linkage (N = 1,622), because of insufficient information on tissue location. We sought tissue from the 2,021 cases verified using medical records, and received tissue from 882. When hospitals were contacted within 10 years of diagnosis, we received 87% of tissue materials; beyond that 10-year mark, we received 32%. Compared with the 2,761 colorectal cancer cases without tissue, the 882 cases with tissue were more likely to be alive, diagnosed more recently during follow-up, and had less-advanced staged disease. Cases with and without tissues were similar with respect to age at diagnosis, smoking, body mass index, physical activity, and other epidemiologic factors. Conclusions: Some of the most important elements in forming a tissue repository included having the cases' hospital contact and surgical accession information as well as contacting patients/next-of-kin and hospitals within 10 years of surgery. Impact: This tissue repository will serve as an important resource for colorectal cancer studies. See all the articles in this CEBP Focus section, “Biomarkers, Biospecimens, and New Technologies in Molecular Epidemiology.” Cancer Epidemiol Biomarkers Prev; 23(12); 2694–702. ©2014 AACR.

Background & Aims Type 2 diabetes mellitus (DM) is associated with an increased risk of colorectal cancer (CRC); it is not clear if this association varies by sex or other factors. Insulin use might also be associated with CRC risk. We investigated associations of type 2 DM and insulin use with CRC risk. Methods The Cancer Prevention Study II Nutrition Cohort is a prospective study of cancer incidence. In 1992 or 1993, adult participants (n = 184,194) completed a detailed, self-administered questionnaire. Follow-up questionnaires were sent in 1997 and every 2 years thereafter. Cox proportional hazards regression analysis was used to calculate relative risks (RR) and 95% confidence intervals (CI), adjusting for covariates. Results After exclusions, 73,312 men and 81,663 women remained in the final analytic cohort; 1567 men (227 with type 2 DM) and 1242 women (108 with type 2 DM) were diagnosed with colon or rectal cancer by 2007. Among men, type 2 DM was associated with increased risk of incident CRC compared to not having type 2 DM (RR: 1.24; 95% CI: 1.08−1.44); risk was higher for participants with type 2 DM using insulin (RR: 1.36; 95% CI: 1.05−1.78), and participants with type 2 DM not using insulin (RR: 1.22, 95% CI: 1.04−1.45). Among women, type 2 DM and insulin use were not associated with risk of incident CRC (RR: 1.01; 95% CI: 0.82−1.23 and RR: 0.95; 95% CI: 0.64−1.41, respectively). Conclusions There is a modest association between type 2 DM and CRC among men, but not women. Insulin use is not associated with a substantially increased risk of CRC.

The obesity epidemic is attributed in part to reduced physical activity. Evidence supports that reducing time spent sitting, regardless of activity, may improve the metabolic consequences of obesity. Analyses were conducted in a large prospective study of US adults enrolled by the American Cancer Society to examine leisure time spent sitting and physical activity in relation to mortality. Time spent sitting and physical activity were queried by questionnaire on 53,440 men and 69,776 women who were disease free at enrollment. The authors identified 11,307 deaths in men and 7,923 deaths in women during the 14-year follow-up. After adjustment for smoking, body mass index, and other factors, time spent sitting (or = 6 vs.3 hours/day) was associated with mortality in both women (relative risk = 1.34, 95% confidence interval (CI): 1.25, 1.44) and men (relative risk = 1.17, 95% CI: 1.11, 1.24). Relative risks for sitting (or = 6 hours/day) and physical activity (24.5 metabolic equivalent (MET)-hours/week) combined were 1.94 (95% CI: 1.70, 2.20) for women and 1.48 (95% CI: 1.33, 1.65) for men, compared with those with the least time sitting and most activity. Associations were strongest for cardiovascular disease mortality. The time spent sitting was independently associated with total mortality, regardless of physical activity level. Public health messages should include both being physically active and reducing time spent sitting.

An international panel of experts characterized the evidence linking alcoholic beverage consumption to pancreatic cancer as limited. Primary concerns include inconsistent results from underpowered studies, residual confounding by smoking, and the question of whether the association varies by type of alcoholic beverage.The association of alcohol intake with pancreatic cancer mortality was examined using data from the Cancer Prevention Study II, a prospective study of US adults 30 years and older. Alcohol consumption was self-reported on a 4-page questionnaire in 1982. Based on follow-up through December 31, 2006, there were 6847 pancreatic cancer deaths among 1,030,467 participants. Multivariable-adjusted relative risks (RRs) and 95% confidence intervals (CIs) were computed using Cox proportional hazards regression analysis controlling for age, sex, race/ethnicity, education, marital status, body mass index, family history of pancreatic cancer, and personal history of gallstones, diabetes mellitus, or smoking.The RRs (95% CIs) of pancreatic cancer mortality associated with current intake of less than 1, 1, 2, 3, and 4 or more drinks per day compared with nondrinkers were 1.06 (0.99-1.13), 0.99 (0.90-1.08), 1.06 (0.97-1.17), 1.25 (1.11-1.42), and 1.17 (1.06-1.29), respectively (P.001 for trend). Consumption of 3 or more drinks per day was associated with pancreatic cancer mortality in never smokers (RR, 1.36; 95% CI, 1.13-1.62) and in ever smokers (RR, 1.16; 95% CI, 1.06-1.27). This association was observed for consumption of liquor (RR, 1.32; 95% CI, 1.10-1.57) but not beer (RR, 1.08; 95% CI, 0.90-1.30) or wine (RR, 1.09; 95% CI, 0.79-1.49).These results strengthen the evidence that alcohol consumption, specifically liquor consumption of 3 or more drinks per day, increases pancreatic cancer mortality independent of smoking.

To examine the association between use of anti-hypertensive drugs and prostate cancer incidence among 48,389 men in the Cancer Prevention Study II Nutrition Cohort. Proportional hazards models were used to calculate rate ratios (RR) for use of Beta-Blockers (BBs), Calcium Channel Blockers (CCBs), and ACE Inhibitors (ACE) and incident prostate cancer in time-dependent analyses. During follow-up from 1997 to 2005, we identified 3,031 cases of incident prostate cancer. Anti-hypertensive use was associated with slightly decreased risk of all (RR = 0.90, 95% CI 0.83–0.98) and organ-confined low-grade prostate cancer (RR = 0.89, 95% CI 0.81–0.99), but was not statistically significantly associated with aggressive-fatal prostate cancer (RR = 0.93, 95% CI 0.79–1.10). BB and ACE inhibitor treatment was associated with an approximately 10% lower risk for all prostate cancer in models adjusted for age and race. These associations were attenuated and lost statistical significance when adjusted for history of heart disease. No trend with duration of use was detected. These results do not support the hypothesis that anti-hypertensive medication is strongly associated with risk of prostate cancer. Confounding by concurrent illness may explain inverse associations seen in other studies.

Background: Studies of postmenopausal hormone therapy and lung cancer incidence have reported positive, negative, and null associations. Most of these studies, however, have had limited ability to control rigorously for cigarette smoking or to examine risk separately by smoking status. Methods: We examined the association between postmenopausal hormone therapy and lung cancer incidence by smoking status among 72,772 women in the Cancer Prevention Study II Nutrition Cohort. Proportional hazards modeling was used to calculate rate ratios (RR). Results: During follow-up from 1992 to 2003, we identified 659 cases of incident lung cancer. Current use of any postmenopausal hormone therapy was significantly associated with decreased risk of incident lung cancer [multivariate RR, 0.76; 95% confidence interval (95% CI), 0.62-0.92]. Similar risk estimates were observed for unopposed estrogen use (RR, 0.76; 95% CI, 0.60-0.94) and for estrogen plus progestin (RR, 0.76; 95% CI, 0.57-1.01). Risk associated with current use of postmenopausal hormone therapy was decreased among never smokers (RR, 0.56; 95% CI, 0.33-0.95) as well as current smokers (RR, 0.76; 95% CI, 0.55-1.05) and former smokers (RR, 0.76; 95% CI, 0.58-0.99). Former hormone use was not associated with lung cancer. No trend with duration of hormone use was detected. Conclusion: These results support the hypothesis that postmenopausal hormone therapy is associated with reduced risk of lung cancer, although the absence of a dose-response relationship weakens the evidence for causality. (Cancer Epidemiol Biomarkers Prev 2008;17(3):655–60)

Background: Obesity has been associated with aggressive prostate cancer. The extent of this association, which varies by stage and grade, remains unclear. The role of recent weight change had not been previously examined.Methods: We examined body mass index (BMI) and weight change in relation to incident prostate cancer by disease stage and grade at diagnosis among 69,991 men in the Cancer Prevention Study II Nutrition Cohort. Participants provided information on height and weight in 1982, and again at enrollment in 1992. During follow-up through June 30, 2003 (excluding the first 2 years of follow-up), we documented 5,252 incident prostate cancers. Cox proportional hazards models were used to estimate rate ratios (RR) and 95% confidence intervals (95% CI).Results: The association between BMI in 1992 and risk of prostate cancer differed by stage and grade at diagnosis. BMI was inversely associated with risk of nonmetastatic low-grade prostate cancer (RR, 0.84; 95% CI, 0.66-1.06), but BMI was positively associated with risk of nonmetastatic high-grade prostate cancer (RR, 1.22; 95% CI, 0.96-1.55) and risk of metastatic or fatal prostate cancer (RR, 1.54; 95% CI, 1.06-2.23). Compared with weight maintenance, men who lost >11 pounds between 1982 and 1992 were at a decreased risk of nonmetastatic high-grade prostate cancer (RR, 0.58; 95% CI, 0.42-0.79).Conclusion: Obesity increases the risk of more aggressive prostate cancer and may decrease either the occurrence or the likelihood of diagnosis of less-aggressive tumors. Men who lose weight may reduce their risk of prostate cancer. (Cancer Epidemiol Biomarkers Prev 2007;16(1):63–9)

Background: Diabetes is associated with a modest increased risk of colorectal cancer (CRC). Evidence also indicates that high endogenous insulin and glucose levels are associated with increased risk of CRC. However, few studies have evaluated whether exogenous insulin, used to treat diabetes, is associated with risk of CRC, and one of these studies reported strongly increased risk among diabetics who had used insulin. Further, few studies have examined the association between diabetes and risk of CRC by gender, tumor phenotype (e.g., sub-site, stage) and other factors, that may be relevant to the etiology of CRC. Methods: The CPS II Nutrition Cohort is a prospective study of cancer incidence including approximately 184,000 U.S. adults aged 50 to 75 at enrollment in 1992-93. At enrollment, participants completed a detailed self-administered questionnaire that included information on demographic, medical, lifestyle, and dietary factors. The questionnaire asked if a participant had been diagnosed by a physician with diabetes mellitus and if the participant was taking insulin to treat the disease. Follow-up questionnaires were sent to cohort members in 1997, and every two years thereafter to update exposure information, including diabetes and insulin-use, and to learn of incident cancers. Colorectal cancer cases in the current study were identified by linkage with the National Death Index (NDI) or by self-reports, subsequently verified by medical record abstraction or linkage with state cancer registries. Results: After exclusions, 73,328 men and 81,670 women remained in the final analytic cohort, of whom 1,444 men and 1,154 women were diagnosed with colon or rectal cancer between enrollment and the end of follow-up in 2007. Among female participants, diabetes and insulin-use were not associated with incident colorectal cancer overall (Relative Risk (RR): 0.98; 95% Confidence Interval (CI): 0.79-1.22 and RR: 0.92; 95% CI: 0.61-1.40, respectively) or when stratified by tumor sub-site in the colon or rectum, stage of disease, or fatality. Among male participants, both diabetes and insulin-use were associated with modestly increased risk of incident colorectal cancer (RR: 1.25; 95% CI: 1.08-1.46 and RR: 1.35; 95% CI: 1.02-1.78, respectively). There were no clear differences in associations with diabetes by subsite or stage. Duration of diabetes was linearly associated with CRC risk among men (p-trend: 0.0002), but not women. Duration of insulin-use was not linearly associated with CRC risk in men or women. Conclusions: Our results from a large U.S. prospective study confirm a modest association between diabetes and colorectal cancer risk among men but not among women. Reasons for these differences are unclear but might be due to sex-differences in hormones or better glucose control among women than men. Our results also suggest that exogenous insulin-use is unlikely to substantially increase risk of colorectal cancer among diabetics. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 101st Annual Meeting of the American Association for Cancer Research; 2010 Apr 17-21; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2010;70(8 Suppl):Abstract nr 1841.