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Cancer / Death · Observational Study
ClinicalTrials.gov · August 18, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record documenting an active, large-scale randomized trial comparing cancer screening (prostate, lung, colorectal, ovarian) against usual care in older U.S. adults. No outcome data are reported in this registry entry; the record describes study design, enrollment, and follow-up extension approved in 2009. Results, when available, will address hard endpoints (cancer-related death and cancer incidence) over extended follow-up.
Observational. Cancer, Death; age from 55 Years; to 74 Years. Intervention: Non-Screening; Screening. Compared with: Usual care (screening practices at the discretion of the participant and their physician).. n = 154,900. 1 site: United States.
Planned enrollment: 154,900 participants (74,000 men and 74,000 women, aged 55–74 years) Randomization: 50/50 allocation to screening arm or usual care arm Primary outcomes: Death and cancer incidence, extended beyond original 13-year follow-up
This is a registry record only; no efficacy or safety results are reported.
This trial is designed to provide definitive evidence on screening effectiveness for four major cancers in older adults. When results become available, they will inform national cancer screening guidelines; no clinical guidance can be drawn from this registry record alone.
This is a registry record for an active observational screening trial with planned follow-up; no results are reported, only study design and enrollment facts.
As stated by the source record.
Quoted from the source exactly as published.
This trial is designed to provide definitive evidence on screening effectiveness for four major cancers in older adults. When results become available, they will inform national cancer screening guidelines; no clinical guidance can be drawn from this registry record alone.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Registry record from ClinicalTrials.gov (NCT00339495). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: ACTIVE_NOT_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 154900 participants (ACTUAL). Conditions: Cancer, Death. Primary outcome measures: Death , Extended beyond T13; Cancer incidence , Extended beyond T13. Brief summary: The Division of Cancer Preventionl (DCP, formerly DCPC), under extramural contracts to 10 U.S. clinical centers, is evaluating the effectiveness of screening for prostate, lung, colorectal and ovarian cancer (The PLCO Trial). In 1996 the NCI Executive Committee approved the expansion of the PLCO Trial to collect additional materials and to conduct additional studies. About, 74,000 men and 74,000 women, aged 55-74 years, have been randomized on a 50/50 basis into screening or usual care arms. Additional blood is collected from screened subjects and saliva for buccal cells from control subjects. Pathologic tissues are obtained for selected cases that develop cancer or selected related diseases (e.g. colon polyps, benign prostatic hyperplasia). Additional questionnaire-based risk and disease-related information is also collected, withconfirmation of disease status from medical records. Genetic, biochemical and questionnairebasedrisk information will be related to the development of cancer and other diseases in this population. Volunteers who provide samples for these studies will not routinely receive their individual results from the Additional Investigation. Subjects requesting such information, however, will be provided their test results. In 2009 the NCI Executive Committee approved the Extended Follow-up of subjects beyond the original 13-year follow-up period. Participants will be reconsented for the release of records to a single NCI-Designated Central Data Collection Center (CDCC), which will administer the annual mailings containing the annual study update questionnaire and a brief (1-2 page) risk factor questionnaire. Individuals who do not consent to release their identifiers to the CDCC will be followed up passively through linkage to state cancer registries and the National Death Index. This protocol Review Application is for (1) the collaboration of intramural scientists in the Division of Cancer Epidemiology and Genetics (DCEG) in the Additional Studies and (2) the coordination, in collaboration with DCP, of the Extended Follow-up.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.