Maryland Prostate Cancer Case-Control Study

马里兰州的大巴尔的摩地区有大量的非洲裔美国人和欧洲裔美国人，这使得该地区最适合研究这两个人群中前列腺癌风险因素暴露的差异。我们设计了一项研究，将使用综合分子流行病学和转化研究方法来检查非洲裔美国男性前列腺癌负担过重的原因，包括非洲裔美国人和欧洲裔美国人患者之间肿瘤生物学差异的研究，并收集血液，尿液，组织样本和调查数据。近年来，已经建立了前列腺癌的其他流行病学研究;然而，只有少数这些研究解决了健康差异研究的需要，并有机会从病例受试者中收集新鲜冷冻的肿瘤标本。我们的研究分两个阶段进行。第一阶段于2005年4月开始，是一项评价征聘程序的试点研究。这一阶段是成功的，2006年4月，在对方案进行微小变更后，开始了完整的研究。研究参与者将是居住在巴尔的摩市及周边地区的非洲裔美国人和欧洲裔美国人男性。该研究将招募1000例前列腺癌病例和1000例基于人群的对照，招募工作将于2015年结束。这些病例是在巴尔的摩的两家医院、退伍军人事务医疗中心和马里兰州大学医疗中心招募的。病例将具有病理学证实的前列腺癌。通过马里兰州机动车部门数据库确定基于人群的对照，并通过年龄和种族与病例进行频率匹配。本研究涉及两份问卷的管理，并从所有研究受试者中采集血液和尿液。如果肿瘤切除术后可用，将从癌症患者中获得新鲜冷冻肿瘤标本。这项研究调查评估了烟草使用、药物使用、职业史、饮食、病史和性史、家族癌症史和社会经济地位。这项研究得到了马里兰州大学资源承包商为肺癌病例对照研究开发的流行病学基础设施的支持。这项肺癌研究正在进行中，前列腺癌研究招募的对照是肺癌研究的联合对照。因此，由我们的承包商招募的基于人群的男性对照组具有双重资格，可同时进行肺癌和前列腺癌研究。为了在前列腺研究中实现病例和对照的年龄和人种匹配，我们将在肺癌研究中对男性对照进行过采样。最近建立的网站（http：//home.ccr.cancer.gov/GEMES/index.html）描述了本研究和正在进行的肺部研究。该网站还介绍了涉及数据共享的合作政策。研究方案和两份问卷可以在以下网站上查阅：http://www3.cancer.gov/intra/lhc/Ambs/Prostate_Cancer_Case_Control_Study_Protocol.pdf http://www3.cancer.gov/intra/lhc/Ambs/Lung_Prostate_Case_Control_Questionnaire.pdf http://www3.cancer.gov/intra/lhc/Ambs/Prostate_Cancer_Supplementary。我们还将检验环境和遗传因素导致非洲裔美国人和欧洲裔美国人之间现有前列腺癌健康差异的假设。分子工作将用于检查肿瘤生物学中的种族/民族差异。目前（2011年9月），我们招募了约695例病例（375名欧洲裔美国人和320名非洲裔美国人）和357名基于人群的对照（214名欧洲裔美国人和143名非洲裔美国人），我们收集了这些个体的血液和尿液。未来的招募率定为每年80例病例和140例对照。合格受试者的参与率非常高，85%的合格病例患者和80%的合格人群对照入组研究。重要的是，非裔美国人和欧裔美国人的参与率非常相似。我们还收集了89例直肠癌切除术后的石蜡包埋和新鲜冷冻组织标本。

The greater Baltimore area in Maryland has a large population of African-Americans and European-Americans, which makes this area most suitable to investigate differences in the exposure to prostate cancer risk factors among these two population groups. We designed a study that will use an integrated molecular epidemiology and translational research approach to examine causes for the excessive burden of prostate cancer among African-American men, including the study of tumor biological differences between African-American and European-American patients, supported by the collection of blood, urine, tissue samples, and survey data. Other epidemiological studies of prostate cancer have been established in recent years; however, only a few of these studies address the need for health disparity research and will have the opportunity to collect fresh-frozen tumor specimens from case subjects. Our study was implemented in two phases. The first phase, which started in April of 2005, constituted a pilot study to evaluate recruitment procedures. This phase was successful and the full study was initiated with minor changes to the protocol in April of 2006. Study participants will be African-American and European-American males who reside in Baltimore city and surrounding areas. The study will recruit 1000 prostate cancer cases and 1000 population-based controls, with recruitment ending in 2015. The cases are recruited at two Baltimore hospitals, the Veterans Affairs Medical Center and the University of Maryland Medical Center. Cases will have pathologically confirmed prostate cancer. The population-based controls are identified through the Maryland Department of Motor Vehicles database, and are frequency-matched by age and race to cases. The study involves the administration of two questionnaires and collection of blood and urine from all study subjects. Fresh-frozen tumor specimens will be obtained from cancer patients if available after prostatectomy. The study survey evaluates tobacco use, medication use, occupational history, diet, medical and sexual history, familial cancer history, and socioeconomic status. The study is supported by an epidemiological infrastructure that has been developed by our resource contractor at the University of Maryland for a lung cancer case-control study. This lung cancer study is ongoing, and the controls that are recruited for the prostate cancer study are joint controls with the lung cancer study. Hence, population-based male controls recruited by our contractor have double eligibility for the concurrent lung and prostate cancer studies. To achieve an age and race matching of cases and controls in the prostate study, we will over-sample for male controls in the lung cancer study. This study and the ongoing lung study are described by a recently established website at (http://home.ccr.cancer.gov/GEMES/index.html). The website also describes the policy for collaborations involving data sharing. Study protocol and the two questionnaires can be accessed at: http://www3.cancer.gov/intra/lhc/Ambs/Prostate_Cancer_Case_Control_Study_Protocol.pdf http://www3.cancer.gov/intra/lhc/Ambs/Lung_Prostate_Case_Control_Questionnaire.pdf http://www3.cancer.gov/intra/lhc/Ambs/Prostate_Cancer_Supplementary Questionnaire.pdf Our study is aimed at identifying candidate differences in risk factor exposure and tumor biology that exist among African-American and European-American men. We will also test the hypothesis that environmental and genetic factors contribute to the existing prostate cancer health disparity among African-Americans and European-Americans. Molecular work will be used to examine race/ethnic differences in tumor biology. Currently (September 2011), we have recruited about 695 cases (375 European-Americans and 320 African-Americans) and 357 population-based controls (214 European-Americans and 143 African-Americans) and we have collected blood and urine from these individuals. Future recruitment rates are set at 80 cases and 140 controls per year. The participation rate of eligible subjects has been very good and 85% of the eligible case patients and 80% of the eligible population-based controls enrolled into the study. Importantly, we had very similar participation rates for African-Americans and European-Americans. We have also collected paraffin-embedded and fresh-frozen tissue specimens for 89 tumors from prostatectomy surgery.