The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial of the National Cancer Institute: History, organization, and status
The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial of the National Cancer Institute: History, organization, and status
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DOI：
10.1016/s0197-2456(00)00097-0
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发表时间：
2000-12-01
期刊：
影响因子：
--
通讯作者：
Kramer, BS
中科院分区：
文献类型：
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作者：
Gohagan, JK;Prorok, PC;Kramer, BS
前列腺、肺、结直肠和卵巢（PLCO）癌症筛查试验在全国10个筛查中心招募了148,000名年龄在55-74岁之间的男性和女性，并将其随机分配到干预组和对照组。对于前列腺癌，男性接受直肠指检和前列腺特异性抗原的血液检查。对于肺癌，男性和女性都接受胸部前位x光检查。对于结直肠癌，男性和女性都要接受60厘米的柔性乙状结肠镜检查。对于卵巢癌，妇女接受CA125肿瘤标志物的血液检查和经阴道超声检查。控制组的成员继续他们的照护。从随机分组开始，两组随访至少13年，以评估健康状况和死亡原因。主要终点是四种PLCO癌症的死亡率，每年占美国男性癌症死亡人数的53%和女性癌症死亡人数的41%。从筛选的参与者收集血液标本，从对照组收集颊细胞DNA，从病例收集组织学切片；它们保存在生物储存库中。参与者完成一份基线调查问卷（包括健康状况和风险因素）和一份饮食调查问卷。12 000多名参加者参加了试验阶段（1994年9月结束）。随后，资格标准发生了变化。截至2000年4月，入学人数超过14.45万。数据被扫描到指定的现场计算机上，通过参与者识别号码上传到协调中心进行质量检查、档案存储，并准备供国家癌症研究所（NCI）使用的分析数据集。科学指导由NCI科学家、试验调查员、外部顾问和一个独立的数据安全和监测委员会提供。通过数据编辑、现场访问、随机记录审计和电话会议来监测性能和数据质量。PLCO试验得到了美国癌症协会的正式认可，并被美国泌尿学协会列为正在进行的最重要的前列腺癌研究之一。招收黑人参与者的特别努力是由美国疾病控制和预防中心共同发起的。对照临床试验2000；21:25 - 272s (C) Elsevier Science Inc. 2000。
The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial is enrolling 148,000 men and women ages 55-74 at ten screening centers nationwide with balanced randomization to intervention and control arms. For prostate cancer, men receive a digital rectal examination and a blood test for prostate-specific antigen. For lung cancer, men and women receive a posteroanterior view chest X-ray. For colorectal cancer, men and women undergo a 60-cm flexible sigmoidoscopy. For ovarian cancer, women receive a blood test for the CA125 tumor marker and transvaginal ultrasound. Members of the control arm continue with their usual care. Follow-up in both groups will continue for at least 13 years from randomization to assess health status and cause of death. The primary endpoint is mortality from the four PLCO cancers, which accounts for about 53% of all cancer deaths in men and 41% of cancer deaths in women in the United States each year. Blood specimens are collected from screened participants, buccal cell DNA from controls, and histology slides from cases; these are maintained in a biorepository. Participants complete a baseline questionnaire (covering health status and risk factors) and a dietary questionnaire. More than 12,000 participants were enrolled in the pilot phase (concluded in September 1994). Changes in the eligibility criteria followed. As of April 2000, enrollment exceeded 144,500. Data are scanned into designated on-site computers for uploading by participant identification number to the coordinating center for quality checks, archival storage, and preparation of analysis datasets for use by the National Cancer Institute (NCI). Scientific direction is provided by NCI scientists, trial investigators, external consultants, and an independent data safety and monitoring board. Performance and data quality are monitored via data edits, site visits, random record audits, and teleconferences. The PLCO trial is formally endorsed by the American Cancer Society and has been ranked by the American Urological Association as one of the most important prostate cancer studies being conducted. Special efforts to enroll black participants are cosponsored by the U.S. Centers for Disease Control and Prevention. Control Clin Trials 2000;21:251S-272S (C) Elsevier Science Inc. 2000.