Maryland Prostate Cancer Case-Control Study

马里兰州的大巴尔的摩地区有大量的非裔美国人和欧裔美国人，这使得该地区最适合研究这两个人群在前列腺癌风险因素暴露方面的差异。我们设计了一项研究，将使用综合的分子流行病学和转化研究方法来检查非裔美国男性前列腺癌过度负担的原因，包括研究非裔美国人和欧裔美国患者之间的肿瘤生物学差异，通过收集血液、尿液、组织样本和调查数据。近年来，其他关于前列腺癌的流行病学研究也得到了证实；然而，这些研究中只有少数解决了健康差异研究的需要，并将有机会从病例受试者中收集新鲜冷冻肿瘤标本。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验性研究。这一阶段是成功的，2006年4月开始了全面的研究，对方案进行了轻微的修改。研究参与者将是居住在巴尔的摩市及周边地区的非裔美国人和欧裔美国人。该研究将招募1000名前列腺癌患者和1000名基于人群的对照组，招募将于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大学医疗中心招募的。病例将有病理证实的前列腺癌。以人口为基础的控制是通过马里兰州机动车辆管理局的数据库确定的，并根据年龄和种族与病例进行频率匹配。该研究包括两份调查问卷的管理，并收集所有研究对象的血液和尿液。新鲜冷冻肿瘤标本将从前列腺切除术后的癌症患者获得。这项研究调查评估了烟草使用、药物使用、饮食、病史和性史、家族癌症史和社会经济地位。这项研究得到了流行病学基础设施的支持，该基础设施是由我们在马里兰大学的资源承包商开发的，用于肺癌病例对照研究。这项肺癌研究还在进行中，前列腺癌研究招募的对照组是肺癌研究的联合对照组。因此，我们的承包商招募的以人群为基础的男性对照者有双重资格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组的年龄和种族匹配，我们将在肺癌研究中对男性对照组进行过采样。最近建立的网站（http://home.ccr.cancer.gov/GEMES/index.html）描述了这项研究和正在进行的肺部研究。该网站还描述了涉及数据共享的合作政策。研究方案和两份调查问卷可在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 .pdf获取。我们的研究旨在确定非裔美国人和欧裔美国人在危险因素暴露和肿瘤生物学方面的差异。我们还将测试环境和遗传因素及其相互作用导致非裔美国人和欧裔美国人之间现有的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，我们已经登记了816例病例（429例欧洲裔美国人和387例非洲裔美国人）和767例基于人群的对照（466例欧洲裔美国人和301例非洲裔美国人），并收集了这些个体的血液和尿液。我们还收集了127例前列腺切除术的石蜡包埋和新鲜冷冻组织标本。未来的招募率设定为每年50-100例病例和50-100例对照，直到达到500名非洲裔美国人和500名欧洲裔美国人的招募密封，以及500名非洲裔美国人和500名欧洲裔美国人的对照。

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, 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 differences in risk factor exposure and tumor biology between African-American and European-American men. We will also test the hypothesis that environmental and genetic factors and their interactions 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, we have enrolled 816 cases (429 European-Americans and 387 African-Americans) and 767 population-based controls (466 European-Americans and 301 African-Americans) and have collected blood and urine from these individuals. We have also collected paraffin-embedded and fresh-frozen tissue specimens form 127 prostatectomy surgeries. Future recruitment rates are set at 50-100 cases and 50-100 controls per year until the recruitment sealing of 500 African-American and 500 European-American cases and 500 African-American and 500 European-American controls is reached.