Clinical trial · Observational
Prostate Lung Colorectal and Ovarian (PLCO) Cancer Screening Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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....
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Death | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Non-Screening
- description
- Participants received their usual care
- label
- Screening
- description
- Participants received trial-provided screening examinations for prostate, lung, colorectal, and ovarian cancer
Primary outcomes (2)
- measure
- Death
- timeFrame
- Extended beyond T13
- description
- Death
- measure
- Cancer incidence
- timeFrame
- Extended beyond T13
- description
- Cancer Incidence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 74 Years
Show eligibility criteria text
* INCLUSION CRITERIA: Men and women aged 55-74 years who do not have a prior history of PLCO tumors and have not undergone routine screening.
References
Publications (9)
- DERIVEDZhang T, Moore SC, Fu S, Albanes D, Liao LM, Loftfield E, Playdon MC, Weinstein SJ, Yu K, Stolzenberg-Solomon RZ. Metabolomic profiling of genotype-derived ABO blood group, secretor status, and Lewis antigens and association with pancreatic ductal adenocarcinoma risk. Am J Epidemiol. 2026 Jun 3;195(6):1572-1584. doi: 10.1093/aje/kwag055. PMID 41804787
- DERIVEDMalcomson FC, Shams-White MM, Reedy J, Huang WY, Moore SC, Loftfield E. Adherence to the 2018 World Cancer Research Fund/American Institute for Cancer Research Cancer Prevention Recommendations and risk of lifestyle-related cancers in the prostate, lung, colorectal, and ovarian cancer screening trial. BJC Rep. 2025 Nov 19;3(1):81. doi: 10.1038/s44276-025-00195-6. PMID 41261199
- DERIVEDWei W, Wang S, Yuan Z, Ren Y, Wu J, Gao X, Wang R, Li J. Plant-based diets and the risk of lung cancer: a large prospective cohort study. Eur J Nutr. 2025 Feb 1;64(2):73. doi: 10.1007/s00394-024-03570-0. PMID 39891747
- DERIVEDJiang Y, Xie Q, Chen R. Breast Cancer Incidence and Mortality in Relation to Hormone Replacement Therapy Use Among Postmenopausal Women: Results From a Prospective Cohort Study. Clin Breast Cancer. 2022 Feb;22(2):e206-e213. doi: 10.1016/j.clbc.2021.06.010. Epub 2021 Jun 26. PMID 34548240
- DERIVEDWang K, Wu Q, Li Z, Reger MK, Xiong Y, Zhong G, Li Q, Zhang X, Li H, Foukakis T, Xiang T, Zhang J, Ren G. Vitamin K intake and breast cancer incidence and death: results from a prospective cohort study. Clin Nutr. 2021 May;40(5):3370-3378. doi: 10.1016/j.clnu.2020.11.009. Epub 2020 Nov 16. PMID 33277073
- DERIVEDMakkar R, Butt J, Huang WY, McGlynn KA, Koshiol J, Pawlita M, Waterboer T, Freedman ND, Murphy G. Seropositivity for Helicobacter pylori and hepatobiliary cancers in the PLCO study. Br J Cancer. 2020 Sep;123(6):909-911. doi: 10.1038/s41416-020-0961-0. Epub 2020 Jun 29. PMID 32595210