NCT01696981

Brief Summary

This clinical trial studies whether screening methods used to diagnose cancer of the prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening tests may help doctors find cancer cells early and plan better treatment for colorectal cancer.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
154,900

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Nov 1993

Longer than P75 for not_applicable

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

Study Progress97%
Nov 1993Jun 2027

Study Start

First participant enrolled

November 16, 1993

Completed
18.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2012

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

July 21, 2014

Completed
13 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Expected
Last Updated

April 30, 2026

Status Verified

January 1, 2026

Enrollment Period

18.5 years

First QC Date

September 28, 2012

Results QC Date

August 30, 2013

Last Update Submit

April 9, 2026

Conditions

Colon CarcinomaRectal Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Colorectal Cancer Deaths

    Colorectal cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.

    Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.

  • Colorectal Cancer Death Rates

    Colorectal cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.

    Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.

Secondary Outcomes (7)

  • Deaths From All Causes

    Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.

  • Death Rates From All Causes

    Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.

  • Colorectal Cancer Incidence

    Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.

  • Colorectal Cancer Incidence Rates

    Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.

  • Complications of Diagnostic Evaluation Following a Positive Screening Test

    One year from screening examination

  • +2 more secondary outcomes

Study Arms (2)

Colorectal Screening

ACTIVE COMPARATOR

Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a DQX at baseline and DHQ at year 3. An ADU (previously referred to as the PSH questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers as all deaths that occur among both screened and control subjects during the trial.

Other: Screening Questionnaire AdministrationProcedure: Sigmoidoscopy

Control

NO INTERVENTION

Participants receive standard medical care. Participants complete a DHQ at baseline.

Interventions

Screening Questionnaire AdministrationOTHER

Undergo questionnaire assessments

Colorectal Screening
SigmoidoscopyPROCEDURE

Undergo a flexible sigmoidoscopy

Also known as: Proctosigmoidoscopy
Colorectal Screening

Eligibility Criteria

Age55 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Men and women who at the time of randomization are less than 55 or greater than or equal to 75 years of age
  • Individuals undergoing treatment for cancer at this time, excluding basal-cell and squamous-cell skin cancer
  • Individuals with known prior cancer of the colon, rectum, lung, prostate
  • This includes primary or metastatic PLCO cancers
  • Individuals with previous surgical removal of the entire colon, one lung, or the entire prostate (men only)
  • Until October 1996, women with previous surgical removal of both ovaries were excluded from the trial. In order to increase the enrollment of women into the trial, beginning in October 1996, these women were no longer excluded for this reason.
  • Individuals who are participating in another cancer screening or cancer primary prevention trial
  • Males who have taken Proscar/Propecia/finasteride in the past 6 months
  • NOTE: Individuals who are already enrolled in the trial when their physician prescribes finasteride are not prevented from taking this medication. As a result, these participants will continue to be screened and followed just as those participants who are not on finasteride.
  • NOTE: Men who are taking Tamoxifen are not excluded from any part of the PLCO Screening Trial.
  • Prior to April 1, 1999 women were excluded from the trial if they were currently taking or had taken Tamoxifen or Evista\\Raloxifene in the past 6 months. As of April 1999 based on a decision from the PLCO Ovary Subcommittee, women who have or are currently taking Tamoxifen or Evista\\Raloxifene are not excluded from participation.
  • Individuals who are unwilling or unable to sign the informed consent form
  • Males who have had more than one PSA blood test in the past three years
  • Individuals who have had a colonoscopy, sigmoidoscopy, or barium enema in the past three years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (6)

  • 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

  • Fan Z, Zhang Y, Yao Q, Liu X, Duan H, Liu Y, Sheng C, Lyu Z, Yang L, Song F, Huang Y, Song F. Effects of joint screening for prostate, lung, colorectal, and ovarian cancer - results from a controlled trial. Front Oncol. 2024 Apr 29;14:1322044. doi: 10.3389/fonc.2024.1322044. eCollection 2024.

    PMID: 38741776DERIVED

  • 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

  • Kunzmann AT, Coleman HG, Huang WY, Cantwell MM, Kitahara CM, Berndt SI. Fruit and vegetable intakes and risk of colorectal cancer and incident and recurrent adenomas in the PLCO cancer screening trial. Int J Cancer. 2016 Apr 15;138(8):1851-61. doi: 10.1002/ijc.29922. Epub 2015 Dec 8.

    PMID: 26559156DERIVED

  • Kunzmann AT, Coleman HG, Huang WY, Kitahara CM, Cantwell MM, Berndt SI. Dietary fiber intake and risk of colorectal cancer and incident and recurrent adenoma in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. Am J Clin Nutr. 2015 Oct;102(4):881-90. doi: 10.3945/ajcn.115.113282. Epub 2015 Aug 12.

    PMID: 26269366DERIVED

MeSH Terms

Conditions

Colonic NeoplasmsRectal Neoplasms

Interventions

Sigmoidoscopy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

ColonoscopyEndoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Results Point of Contact

Title
Paul F. Pinsky, Ph.D.
Organization
Early Detection Research Group, NCI, NIH
pinskyp@mail.nih.gov
301-496-8544

Study Officials

  • Christine D Berg

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2012

First Posted

October 2, 2012

Study Start

November 16, 1993

Primary Completion

May 21, 2012

Study Completion (Estimated)

June 30, 2027

Last Updated

April 30, 2026

Results First Posted

July 21, 2014

Record last verified: 2026-01

Locations

US(1)