Design of the prostate, lung, colorectal and ovarian (PLCO) cancer screening trial

摘要: The objectives of the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial are to determine in screenees ages 55-74 at entry whether screening with flexible sigmoidoscopy (60-cm sigmoidoscope) can reduce mortality from colorectal cancer, chest X-ray lung men digital rectal examination (DRE) plus serum prostate-specific antigen (PSA) prostate women CA125 transvaginal ultrasound (TVU) ovarian cancer. Secondary assess variables other than for each interventions including sensitivity, specificity, positive predictive value; incidence, stage, survival cancer cases; investigate biologic and/or prognostic characterizations tumor tissue biochemical products as intermediate endpoints. design is a multicenter, two-armed, randomized trial 37,000 females males two arms. In intervention arm, PSA tests performed entry, then annually 5 years. DRE, TVU, exams 3 Sigmoidoscopy 5-year point. Participants control arm follow their usual medical care practices. will be followed least 13 years randomization ascertain all cancers prostate, lung, colorectum, ovary, well deaths causes. A pilot phase was undertaken randomization, screening, data collection procedures estimate parameters such compliance contamination levels. This paper describes eligibility, consent, features trial, procedures, an outline follow-up procedures. Sample-size calculations reported, analysis plan presented.