Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial

前列腺癌、肺癌、结直肠癌和卵巢癌 (PLCO) 筛查试验

• 批准号: 8335323
• 负责人: KAREN STEINMETZ
• 金额: $ 27.77万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-09-30 至 2012-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8335323
• 关键词: Address; African American; Age; Aliquot; Anterior; Antigens; Biochemical Genetics; Biological Markers; Blood specimen; CA-125 Antigen; Cancer Control; Caring; Cells; Cessation of life; Characteristics; Chest; Clinical Data; Collaborations; Colorectal; Colorectal Cancer; DNA; Data; Development; Diagnosis; Diagnostic; Dietary Factors; Dietary Questionnaires; Digital Rectal Examination; Disease; Early Diagnosis; Enrollment; Etiology; Female; Flexible fiberoptic sigmoidoscopy; Food; Frequencies; Future; Health Status; Healthcare; Hispanic Americans; Human Subject Research; Incidence; Intervention; Life Style; Location; Lung; Lung Neoplasms; Malignant Neoplasms; Malignant neoplasm of lung; Malignant neoplasm of ovary; Malignant neoplasm of prostate; Medical; Minority; Molecular; Multi-Institutional Clinical Trial; National Cancer Institute; Ovarian; Participant; Phase III Clinical Trials; Plasma; Population; Predictive Value; Primary Health Care; Process; Prostate; Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial; Prostate-Specific Antigen; Prostatic Neoplasms; Provider; Questionnaires; Randomized; Randomized Controlled Trials; Recording of previous events; Rectal Cancer; Rectal Tumors; Regimen; Resources; Risk Assessment; Risk Factors; Sample Size; Sampling; Screening for Ovarian Cancer; Screening for Prostate Cancer; Screening procedure; Sensitivity and Specificity; Serum; Sigmoidoscopes; Site; Smoker; Specimen; Staging; Testing; Time; Tissue Microarray; Transvaginal Ultrasound; Tumor Tissue; United States; Visit; Whole Blood; Woman; aged; anticancer research; arm; biobank; cancer diagnosis; cancer epidemiology; cancer genetics; cancer prevention; colorectal cancer screening; control trial; digital; experience; genetic risk factor; improved; lung cancer screening; male; men; mortality; ovarian neoplasm; randomized trial; rectal; treatment as usual

The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial is a large scale, randomized controlled trial to determine whether certain screening tests will reduce the number of deaths from these cancers. PLCO is a multi-institutional clinical trial being conducted at ten sites, geographically and demographically disparate, around the U.S. This controlled trial is a Phase III trial conducting human subjects research. PLCO enrolled 154,942 male and female participants. The PLCO participants are comparable to the general United States population. Life style, dietary and risk factor information was collected from participants. The intervention arm received for lung cancer, posterior-anterior (PA) chest x-ray annually for four screens (except never smokers who received three annual screens), flexible sigmoidoscopy (FSG) at enrollment and again at the fourth or sixth annual screening interval depending on time of enrollment to screen for colorectal cancer. For prostate cancer, men received six annual prostate screens with prostate-specific antigen (PSA) and four digital rectal exams (DRE). Women were screened for ovarian cancer with CA-125 antigen for six annual screens and with transvaginal ultrasound (TVU) for four annual screens. The usual care (control) arm received regular health care from their primary care provider. Whole blood, sequential serum samples and one plasma sample were collected from the intervention arm. Aliquots from these samples are stored in the PLCO Biorepository through collaboration with the Division of Cancer Epidemiology and Genetics (DCEG). The usual care arm provided buccal cell DNA samples which are also stored in the PLCO Biorepository. The PLCO Biorepository currently has over 2.9 million specimens that can be used for etiologic and early marker studies. PLCO is collecting colo-rectal, ovarian, prostate and lung tumor tissue from those participants who have developed cancer. Tissue microarrays are then constructed. STUDY DESIGN The PLCO is a two-armed, randomized trial in which more than 38,000 men were screened for lung, colorectal, and prostate cancers and approximately 39,000 women were screened for lung, colorectal, and ovarian cancers. Equal numbers of men and women participating as controls continue their usual medical care practices. The eligible age range at entry was 55-74 years. Both screened and control participants are to be followed for at least 13 years from randomization for cancer and death ascertainment to determine if the screening regimen results in reduced disease-specific mortality. Baseline information including demographic characteristics, known risk factors for the cancers under study, and screening history were collected from all participants. In addition, participants completed dietary, food frequency questionnaires and subsequently a risk factor questionnaire that supplements the baseline data provided at the time they enrolled. Blood samples collected at each screening visit were processed into separate components and stored for future molecular analyses. Control participants provided Buccal cell DNA. Participants in both the intervention and control arms completed a dietary questionnaire. All participants also provide annual health status information. Special efforts made to enhance the recruitment of minorities occurred at several screening locations. One site in Detroit, MI focused efforts on increasing the participation of African Americans. A site in Denver, CO hired Spanish speaking staff to enhance the number of Hispanic Americans enrolled in PLCO. BIOREPOSITORY The PLCO Biorepository contains approximately 2.9 million biologic specimens collected during the six screening years. These samples include serum, plasma and buffy coat and DNA samples. These specimens are an invaluable resource for cancer research. Some of the characteristics that make the PLCO biospecimens uniquely valuable include: - Large sample size allows statistical power - Specimens are collected prospectively, before cancer diagnosis - Serial specimens are collected at each of the 6 annual screenings - Detailed background and clinical data are available The PLCO Etiology and Early Marker Studies (EEMS) component is an integral part of the PLCO Trial. The PLCO EEMS has two main focuses: etiologic studies that investigate the environmental, biochemical and genetic risk factors for cancer; and early detection studies that aim to develop reproducible, diagnostics-ready biomarkers of early disease. The PLCO EEMS directly addresses the following strategic priorities of the National Cancer Institute: - Understand the causes and mechanisms of cancer - Improve early detection and diagnosis

前列腺癌、肺癌、结直肠癌和卵巢癌(PLCO)筛查试验是一项大规模的随机对照试验，旨在确定某些筛查测试是否将减少这些癌症的死亡人数。PLCO是一项多机构临床试验，在美国各地的十个地点进行，地理和人口统计学上不同。这项对照试验是进行人类受试者研究的第三阶段试验。PLCO招募了154,942名男性和女性参与者。《公共部门会计准则》的参与者与美国的一般人口相当。从参与者那里收集生活方式、饮食和危险因素信息。对于肺癌，干预组接受每年四次筛查的前后(PA)胸部X光检查(从不吸烟者每年接受三次筛查除外)，登记时进行柔性乙状结肠镜(FSG)检查，并根据登记时间再次进行第四次或第六次年度筛查，以筛查结直肠癌。对于前列腺癌，男性每年接受六次前列腺特异性抗原(PSA)筛查和四次直肠指诊(DRE)。妇女每年接受6次CA-125抗原筛查和4次经阴道超声(TVU)筛查。通常的护理(对照)组从他们的初级保健提供者那里得到定期的卫生保健。从介入臂采集全血、序贯血清和1例血浆样本。通过与癌症流行病学和遗传学司(DCEG)合作，这些样本的等分被存储在PLCO生物储存库中。通常的护理机构提供了口腔细胞DNA样本，这些样本也存储在PLCO生物储存库中。PLCO生物资料库目前有超过290万份标本，可用于病因学和早期标志物研究。PLCO正在收集患有癌症的参与者的结直肠癌、卵巢癌、前列腺癌和肺癌组织。然后构建组织微阵列。 研究设计 PLCO是一项双臂随机试验，超过38,000名男性接受了肺癌、结直肠癌和前列腺癌的筛查，大约39,000名女性接受了肺癌、结直肠癌和卵巢癌的筛查。作为对照组的同等数量的男性和女性继续他们通常的医疗保健做法。符合条件的年龄范围为55-74岁。筛查和对照参与者都将从癌症和死亡的随机确定开始进行至少13年的跟踪调查，以确定筛查方案是否导致特定疾病死亡率的降低。 从所有参与者那里收集了基线信息，包括人口统计特征、所研究癌症的已知风险因素和筛查历史。此外，参与者完成了饮食、食物频率问卷，随后完成了风险因素问卷，补充了他们登记时提供的基线数据。在每次筛查中收集的血液样本被处理成单独的成分，并存储起来用于未来的分子分析。对照组参与者提供了口腔细胞DNA。干预组和对照组的参与者都完成了一份饮食调查问卷。所有参与者还提供年度健康状况信息。 在几个甄别地点为加强招募少数群体作出了特别努力。在底特律的一个地点，MI将努力集中在增加非裔美国人的参与上。位于丹佛的一家网站聘请了会说西班牙语的工作人员，以增加在PLCO注册的西班牙裔美国人的数量。 生物资源库 PLCO生物资料库包含在六个筛选年中收集的大约290万个生物标本。这些样本包括血清、血浆、棕黄色大衣和DNA样本。这些标本是癌症研究的宝贵资源。使PLCO生物标本具有独特价值的一些特征包括： --样本量大，统计能力强 -在癌症诊断之前，前瞻性地收集样本 -在6次年度筛选中的每一次中收集系列标本 -提供详细的背景和临床数据 PLCO病因学和早期标志物研究(EEM)部分是PLCO试验的组成部分。PLCO EEM有两个主要关注点：调查癌症的环境、生化和遗传风险因素的病因学研究；旨在开发可重现的、诊断就绪的早期疾病生物标记物的早期检测研究。公共部门会计准则直接涉及国家癌症研究所的以下战略优先事项： -了解癌症的原因和机制 -提高早期发现和诊断能力