Colonoscopy or Fecal Occult Blood Test in Screening Healthy Participants for Colorectal Cancer (00-046)

March 6, 2026 updated by: Memorial Sloan Kettering Cancer Center

Colonoscopy Screening Trial

RATIONALE: Screening tests, such as colonoscopy and fecal occult blood test, may help doctors find tumor cells early and plan better treatment for colorectal cancer.

PURPOSE: This randomized phase III trial is studying colonoscopy to see how well it works compared to fecal occult blood test in screening healthy participants for colorectal cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

OBJECTIVES:

  • Compare the neoplastic outcome of participants at average risk for colorectal cancer who undergo colonoscopy vs annual fecal occult blood tests.
  • Compare the endoscopic and clinical resources required for these screening methods in these participants.
  • Compare the benefit-to-harm ratio in participants undergoing these screening methods.
  • Determine the level of participation of participants undergoing these screening methods.

OUTLINE: This is a randomized, two-part, multicenter study.

Participants are asked whether they are interested in participating in a randomized controlled trial of colorectal cancer screening.

  • Screening colonoscopy feasibility study I (accrual completed as of 12/14/2004): Participants who are interested in participating in a screening trial are randomized to 1 of 2 screening arms.

    • Arm I: Participants undergo baseline screening colonoscopy.
    • Arm II: Participants receive standard care.

  • Screening colonoscopy feasibility study II: Participants who are interested in participating in a screening trial are randomized to 1 of 2 screening arms.

    • Arm I: Participants undergo baseline screening colonoscopy. Participants are given individualized recommendations for further surveillance based on the results of the colonoscopy.
    • Arm II: Participants undergo a baseline fecal occult blood test (FOBT). Participants are given individualized recommendations for further surveillance based on the results of the FOBT. Participants with negative baseline FOBT undergo FOBT annually for up to 4 years in the absence of a positive FOBT.

All participants are followed annually for up to 4 years.

PROJECTED ACCRUAL: A total of 1,402 participants (701 per screening arm) have been accrued for feasibility study I within 3 years (accrual completed as of 12/14/2004). An additional 3,550 participants (1,775 per screening arm) will be accrued for feasibility study II within 5 years.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4952

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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
    • Louisiana
      • Shreveport, Louisiana, United States, 71130-3932
        • Feist-Weiller Cancer Center at Louisiana State University Health Sciences
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Masonic Cancer Center at University of Minnesota (Data collection only)
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
    • Washington
      • Seattle, Washington, United States, 98101-1466
        • Kaiser Permanente Washington Health Research Institute (Data collection only)

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

DISEASE CHARACTERISTICS:

  • Healthy participants at average risk for developing colorectal cancer
  • No history of colorectal cancer
  • No history of familial adenomatous polyposis
  • More than 5 years since prior flexible sigmoidoscopy
  • No prior colonoscopy

PATIENT CHARACTERISTICS:

Age

  • 50 to 69 (40 to 69 at the Louisiana State University participating site)

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Cardiovascular

  • No myocardial infarction within the past year
  • No congestive heart failure

Pulmonary

  • No chronic obstructive pulmonary disease

Gastrointestinal

  • No history of ulcerative colitis
  • No history of Crohn's disease
  • No history of inflammatory bowel disease

Other

  • No serious comorbid condition
  • No consumption of red meat within 3 days prior to and during FOBT (feasibility study II, arm II only)

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No concurrent chemotherapy other than for nonmelanoma skin cancer

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No vitamin C consumption > 250 mg within 3 days prior to and during fecal occult blood testing (FOBT) (feasibility study II arm II only)
  • No nonsteroidal anti-inflammatory drugs within 7 days prior to and during FOBT (feasibility study II, arm II only)
  • No concurrent anticoagulants
  • No concurrent anticancer therapy except for treatment of nonmelanoma skin cancer

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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study I- Arm I
Participants undergo baseline screening colonoscopy
Procedure: screening colonoscopy
Patients undergo baseline screening colonoscopy
Other: Study I- Arm II
Participants receive standard care
Procedure: fecal occult blood test
Participants undergo a baseline fecal occult blood test (FOBT)
Procedure: standard follow-up care
Standard care
Experimental: Study II- Arm I
Participants undergo baseline screening colonoscopy. Participants are given individualized recommendations for further surveillance based on the results of the colonoscopy.
Procedure: screening colonoscopy
Patients undergo baseline screening colonoscopy
Active Comparator: Study II- Arm II
Participants undergo a baseline fecal occult blood test (FOBT). Participants are given individualized recommendations for further surveillance based on the results of the FOBT. Participants with negative baseline FOBT undergo FOBT annually for up to 4 years in the absence of a positive FOBT.
Procedure: fecal occult blood test
Participants undergo a baseline fecal occult blood test (FOBT)
Procedure: annual screening
Participants with negative baseline FOBT undergo FOBT annually for up to 4 years in the absence of a positive FOBT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Neoplastic findings as assessed by screening colonoscopy vs annual fecal occult blood test (FOBT)-directed colonoscopy
Time Frame: 5 years
5 years
Burden on endoscopic and clinical resources
Time Frame: 5 years
5 years
Harms associated with screening colonoscopy vs annual FOBT-directed colonoscopy
Time Frame: 5 years
5 years
Benefit-to-harm ration for screening colonoscopy vs annual FOBT-directed colonoscopy
Time Frame: 5 years
5 years
Level of participation in screening with FOBT-directed colonoscopy vs a single colonoscopy
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Sloan Kettering Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ann Zauber, PhD, Memorial Sloan Kettering Cancer Center

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

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 25, 2000

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 5, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 5, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2005

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2005

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 00-046
  • MSKCC-00046A
  • UMN-2003NT062

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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