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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01696981
First received: September 28, 2012
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

This results record (NCT01696981) addresses whether colorectal cancer screening tests reduce colorectal cancer mortality by helping doctors find cancer cells early and plan better treatment for colorectal cancer. The colorectal cancer screening tests are part of a trial that addresses the screening of four cancer sites, each with their own results record: prostate (NCT00002540), lung (NCT01696968), colorectal (NCT01696981), and ovarian (NCT01696994).


Condition Intervention
Colon Cancer
Rectal Cancer
Procedure: sigmoidoscopy
Other: screening questionnaire administration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Screening
Official Title: Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Colorectal Cancer Deaths [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years. ] [ Designated as safety issue: No ]
    Colorectal cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.

  • Colorectal Cancer Death Rates [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Deaths From All Causes [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years. ] [ Designated as safety issue: No ]
    Deaths from all causes were compared between the colorectal cancer screening arm and the usual care arm.

  • 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. ] [ Designated as safety issue: No ]
    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.

  • Colorectal Cancer Incidence [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years. ] [ Designated as safety issue: No ]
    Colorectal cancer diagnoses confirmed by medical record abstraction.

  • Colorectal Cancer Incidence Rates [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years. ] [ Designated as safety issue: No ]
    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.

  • Complications of Diagnostic Evaluation Following a Positive Screening Test [ Time Frame: One year from screening examination ] [ Designated as safety issue: Yes ]
    Number of participants who experienced complications during diagnostic work-up of a positive colorectal examination.

  • T0 (Baseline) FSG Screening Results [ Time Frame: T0 (at study entry) ] [ Designated as safety issue: No ]
    Flexible sigmoidoscopy (FSG) result

  • T3/T5 FSG Screening Result [ Time Frame: T3 (three years after entry) or T5 (five years after entry) ] [ Designated as safety issue: No ]
    Flexible sigmoidoscopy (FSG) result


Enrollment: 154900
Study Start Date: November 1993
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: sigmoidoscopy
Undergo a flexible sigmoidoscopy
Other: screening questionnaire administration
Undergo questionnaire assessments

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.

  Eligibility

Ages Eligible for Study:   55 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Exclusion Criteria Exclusion Criteria (the following criteria are applied to all participants in the study, all of whom are also included in the lung outcome. All men are included in the prostate outcome and women in the ovarian outcome):

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01696981

Locations
United States, Maryland
Mark O Hatfield-Warren Grant Magnuson Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Christine Berg Mark O Hatfield-Warren Grant Magnuson Clinical Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01696981     History of Changes
Other Study ID Numbers: NCI-2012-01757, NCI-2012-01757, PLCO-1, CDR0000078532, NCI-P93-0050, PLCO-Colorectal
Study First Received: September 28, 2012
Results First Received: August 30, 2013
Last Updated: June 19, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Colonic Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 21, 2014