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....

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

154,900

participants targeted

Target at P75+ for all trials

Timeline

8mo left

Started May 1998

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

28.7 years study duration

Study Progress98%

May 1998Dec 2026

Study Start

First participant enrolled

May 1, 1998

Completed

8.1 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed

20.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 29, 2026

Status Verified

December 2, 2025

Enrollment Period

28.7 years

First QC Date

June 19, 2006

Last Update Submit

April 28, 2026

Conditions

Cancer Death

Keywords

ProstateScreening TrialOvarianLungColorectal

Outcome Measures

Primary Outcomes (2)

Death
Death
Extended beyond T13
Cancer incidence
Cancer Incidence
Extended beyond T13

Study Arms (2)

Non-Screening

Participants received their usual care

Screening

Participants received trial-provided screening examinations for prostate, lung, colorectal, and ovarian cancer

Eligibility Criteria

Age55 Years - 74 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Community samples from ten US screening centers: Birmingham AL, Denver CO, Detroit MI, Honolulu HI, Marshfield WI, Minneapolis MN, Pittsburgh PA, Salt Lake City UT, St Louis MO, and Washington DC

You may qualify if:

Men and women aged 55-74 years who do not have a prior history of PLCO tumors and have not undergone routine screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

National Cancer Institute (NCI)lead

Study Sites (1)

Westat, Inc.

Rockville, Maryland, 20850, United States

Location

Related Publications (8)

Malcomson 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: 41261199DERIVED
Wei 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: 39891747DERIVED
Jiang 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: 34548240DERIVED
Wang 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: 33277073DERIVED
Makkar 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: 32595210DERIVED
Kunzmann AT, Coleman HG, Huang WY, Berndt SI. The association of lifetime alcohol use with mortality and cancer risk in older adults: A cohort study. PLoS Med. 2018 Jun 19;15(6):e1002585. doi: 10.1371/journal.pmed.1002585. eCollection 2018 Jun.
PMID: 29920516DERIVED
Playdon MC, Ziegler RG, Sampson JN, Stolzenberg-Solomon R, Thompson HJ, Irwin ML, Mayne ST, Hoover RN, Moore SC. Nutritional metabolomics and breast cancer risk in a prospective study. Am J Clin Nutr. 2017 Aug;106(2):637-649. doi: 10.3945/ajcn.116.150912. Epub 2017 Jun 28.
PMID: 28659298DERIVED
Piper MR, Freedman DM, Robien K, Kopp W, Rager H, Horst RL, Stolzenberg-Solomon RZ. Vitamin D-binding protein and pancreatic cancer: a nested case-control study. Am J Clin Nutr. 2015 Jun;101(6):1206-15. doi: 10.3945/ajcn.114.096016. Epub 2015 Apr 22.
PMID: 25904602DERIVED

MeSH Terms

Conditions

NeoplasmsDeath

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Steven C Moore, Ph.D.
National Cancer Institute (NCI)
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: NIH
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

May 1, 1998

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 29, 2026

Record last verified: 2025-12-02

Locations

US(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Non-Screening

Screening

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (8)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations