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Colonoscopy vs. stool test: which screens better for colon cancer?

NCT ID NCT00102011

Prevention Sponsor: Memorial Sloan Kettering Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial compared colonoscopy with annual fecal occult blood tests for colorectal cancer screening in nearly 5,000 healthy adults aged 50-69. The goal was to see which method finds more early tumors and has a better balance of benefits and harms. Participants were randomly assigned to one screening approach and followed for up to 4 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
screening colonoscopy and fecal occult blood test
What this could lead to
If successful, this could show that colonoscopy is more effective than stool tests for preventing colorectal cancer through early detection.
What could go wrong
This trial is completed and results are already known; it may not change current guidelines if no major benefit is found. Screening procedures also carry risks like bleeding or perforation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 4,952 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2000

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 69 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

colonic neoplasm colorectal neoplasm rectal neoplasm colorectal cancer prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer

Contacts and locations

Locations

  • Feist-Weiller Cancer Center at Louisiana State University Health Sciences

    Shreveport, Louisiana, 71130-3932, United States

  • Kaiser Permanente Washington Health Research Institute (Data collection only)

    Seattle, Washington, 98101-1466, United States

  • Masonic Cancer Center at University of Minnesota (Data collection only)

    Minneapolis, Minnesota, 55455, United States

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065, United States

More trials for these conditions

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