Screening for Colorectal Cancer in Older Patients (PLCO Screening Trial)

March 9, 2024 updated by: National Cancer Institute (NCI)

Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To determine whether screening with flexible sigmoidoscopy (60-cm sigmoidoscope) can reduce mortality from colorectal cancer in women and men aged 55-74 at study entry.

SECONDARY OBJECTIVES:

I. To assess screening variables, other than mortality, for each of the interventions including sensitivity, specificity, and positive predictive value.

II. To assess the incidence, stage, and survival of cancer cases. III. To investigate the mortality predictive value of biologic and/or prognostic characterizations of tumor tissue as intermediate endpoints.

IV. To conduct biomolecular and genetic research into factors associated with cancer carcinogenesis and promotion, as well as the early detection of these factors.

OUTLINE: Participants in the overall PLCO study are stratified by screening center, gender, and age (55-59 vs 60-64 vs 65-69 vs 70-74). Participants are randomized to 1 of 2 arms (control vs screening).

ARM I (Control): Participants receive standard medical care. Participants complete a Diet History Questionnaire (DHQ) at baseline.

ARM II (Colorectal Screening): Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. A scheduling and tracking procedure is implemented to ensure regular attendance at repeat screens for participants screened negative or for those who are designated suspicious or positive at screening but for whom subsequent diagnostic procedures do not reveal colorectal cancer (follow-up diagnostic procedures are through their own medical care environment). Participants diagnosed with colorectal cancer via a screening test are referred for treatment in accordance with current accepted practice for appropriate stage of disease, patient age, and medical condition; a procedure is provided for contact with qualified medical personnel to insure appropriate therapy.

Participants complete a Dietary Questionnaire (DQX) at baseline and DHQ at year 3. An Annual Study Update (ADU) (previously referred to as the Periodic Survey of Health [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.

After completion of screening, participants are followed up for at least 13 years.

Study Type

Interventional

Enrollment (Actual)

154900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Participants receive standard medical care. Participants complete a DHQ at baseline.
Active Comparator: Colorectal Screening
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 Administration
Undergo questionnaire assessments
Procedure: Sigmoidoscopy
Undergo a flexible sigmoidoscopy
Other Names:
  • Proctosigmoidoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Colorectal Cancer Deaths
Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
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
Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deaths From All Causes
Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
Deaths from all causes were compared between the colorectal cancer screening arm and the usual care arm.
Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
Death Rates From All Causes
Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
Deaths from all causes were compared between the colorectal cancer screening arm and the usual care arm. 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.
Colorectal Cancer Incidence
Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
Colorectal cancer diagnoses confirmed by medical record abstraction.
Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
Colorectal Cancer Incidence Rates
Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
Colorectal cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as colorectal cancer diagnoses divided by person years at risk for colorectal cancer.
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
Time Frame: One year from screening examination
Number of participants who experienced complications during diagnostic work-up of a positive colorectal examination.
One year from screening examination
T0 (Baseline) FSG Screening Results
Time Frame: T0 (at study entry)
Flexible sigmoidoscopy (FSG) result
T0 (at study entry)
T3/T5 FSG Screening Result
Time Frame: T3 (three years after entry) or T5 (five years after entry)
Flexible sigmoidoscopy (FSG) result
T3 (three years after entry) or T5 (five years after entry)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Christine D Berg, National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 1993

Primary Completion (Actual)

May 21, 2012

Study Completion (Estimated)

March 11, 2025

Study Registration Dates

First Submitted

September 28, 2012

First Submitted That Met QC Criteria

October 1, 2012

First Posted (Estimated)

October 2, 2012

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-01757 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • CDR0000078532
  • NCI-P93-0050
  • PLCO-1
  • PLCO-Colorectal (Other Identifier: National Cancer Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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