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调查这两组人在前列腺癌风险因素暴露方面的差异。我们设计了一种新的方案，提出了分子流行病学和转化研究以及血液、尿液、组织样本和调查数据的收集。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点研究。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。这项研究将招募600名前列腺癌患者和600名以人群为基础的对照组。这些是目前的招聘目标。然而，随着2015年的招募，这些病例可能会增加到1000例和1000例对照。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。在可能的情况下，将从癌症患者那里获得新鲜冷冻的肿瘤标本。两份问卷由主问卷和补充问卷组成。问卷评估家族癌症史、烟草使用、药物使用、职业史、社会经济地位和前列腺癌的危险因素。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，我们将在肺部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肿瘤生物学和危险因素暴露方面的差异。我们将测试环境和遗传因素导致非裔美国人和欧裔美国人之间存在的前列腺癌健康差异的假设。我们还将使用分子工作来检查肿瘤生物学中的种族/民族差异。目前，我们已经招募了大约480例病例和240例基于人群的对照，并收集了这些人的血液和尿液。未来的招聘率定为每年80-100例和120例对照。符合条件的受试者的参与率非常好，85%的符合条件的病例患者和80%的符合条件的基于人群的对照组参加了研究。重要的是，非裔美国人和欧裔美国人的参与率是一样的。我们还收集了约60例石蜡包埋和新鲜冷冻肿瘤。

The greater Baltimore, Maryland area 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 groups. We designed a new protocol that proposes molecular epidemiology and translational research studies and 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 600 prostate cancer cases and 600 population-based controls. These are the current recruitment targets. However, those may increase to 1000 cases and 1000 controls with recruitment into 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 where available. The two questionnaires consist of a main questionnaire and a supplemental questionnaire. The questionnaires evaluate familial cancer history, tobacco use, medication use, occupational history, socioeconomic status, and risk factors for prostate cancer. 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 male controls in the lung 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 the differences in tumor biology and risk factor exposure that exist among African-American and European-American men. We will test the hypothesis that environmental and genetic factors contribute to the existing prostate cancer health disparity among African-Americans and European-Americans. We will also use molecular work to examine race/ethnic differences in tumor biology. Currently, we have recruited about 480 cases and 240 population-based controls and we have collected blood and urine from these individuals. Future recruitment rates are set at 80-100 cases and 120 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 the same participation rates for African-Americans and European-Americans. We also collected about 60 paraffin-embedded and fresh-frozen tumors.