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50,000 veterans in landmark study to settle colonoscopy vs. stool test debate

NCT ID NCT01239082

Prevention Sponsor: VA Office of Research and Development 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 2 times

Summary

This large study compares two common colorectal cancer screening methods: colonoscopy and annual fecal immunochemical testing (FIT). Over 50,000 veterans aged 50-75 will be randomly assigned to one of the two screenings and followed for 10 years. The goal is to see which approach better prevents deaths from colorectal cancer.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

50,126 people

The number who actually took part.

Started

Apr 2012

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

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

Ages

50 to 75 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.

Inclusion Criteria: * Veteran * Able to provide informed consent Exclusion Criteria: * Symptoms of lower gastrointestinal tract disease warranting colonoscopic evaluation, including: * More than one episode of rectal bleeding within the past 6 months * Documented iron deficiency anemia * Significant documented unintentional weight loss (\>10% of baseline weight) over 6 months * Family history of CRC in a first degree relative at any age * Prior history of colonic disease including: * Inflammatory bowel disease (e.g. ulcerative colitis or Crohn's disease) * One or more colorectal neoplastic polyps (i.e. adenomas) * Colorectal cancer * Prior history of colonic resection * Prior colonic examination, including: * Colonoscopy within the past 9.5 years * Sigmoidoscopy within the past 5 years * Barium enema within the past 5 years * CT colonography within the past 5 years * Guaiac-based fecal occult blood test (gFOBT) or Fecal immunochemical test (FIT) in the past 10 months * Stool DNA test within the past 3 years * Pregnancy * Prisoner * Significant comorbidity that would preclude benefit from screening or pose significant risk for the performance of colonoscopy (e.g. severe lung disease, end-stage renal disease, end-stage liver disease, severe heart failure, recent diagnosis of cancer (with the exception of non-melanoma skin cancer)) * Participation in a concurrent interventional study pertaining to the colon or rectum (including studies of colonoscopy or colorectal cancer screening. Waivers to this exclusion criteria can be requested and granted with the approval of the CONFIRM study co-chairs, the Cooperative Study Program and the leadership of the other study. * Likely inability to track the individual over time (e.g. no permanent address at the time of screening for study entry)

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Conditions

The condition(s) this trial relates to.

colorectal 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

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    Decatur, Georgia, 30033-4004, United States

  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

    Baltimore, Maryland, 21201, United States

  • Central Arkansas Veterans Healthcare System, Little Rock, AR

    Little Rock, Arkansas, 72205, United States

  • Clarksburg Louis A. Johnson VA Medical Center, Clarksburg, WV

    Clarksburg, West Virginia, 26301-4155, United States

  • Durham VA Medical Center, Durham, NC

    Durham, North Carolina, 27705-3875, United States

  • East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

    East Orange, New Jersey, 07018, United States

  • James A. Haley Veterans' Hospital, Tampa, FL

    Tampa, Florida, 33612, United States

  • Jesse Brown VA Medical Center, Chicago, IL

    Chicago, Illinois, 60612, United States

  • John D. Dingell VA Medical Center, Detroit, MI

    Detroit, Michigan, 48201-1916, United States

  • Kansas City VA Medical Center, Kansas City, MO

    Kansas City, Missouri, 64128-2226, United States

  • Louis Stokes VA Medical Center, Cleveland, OH

    Cleveland, Ohio, 44106-1702, United States

  • Manchester VA Medical Center, Manchester, NH

    Manchester, New Hampshire, 03104-7007, United States

  • Memphis VA Medical Center, Memphis, TN

    Memphis, Tennessee, 38104-2127, United States

  • Miami VA Healthcare System, Miami, FL

    Miami, Florida, 33125, United States

  • Michael E. DeBakey VA Medical Center, Houston, TX

    Houston, Texas, 77030-4211, United States

  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis, Minnesota, 55417-2309, United States

  • North Florida/South Georgia Veterans Health System, Gainesville, FL

    Gainesville, Florida, 32608-1135, United States

  • Northport VA Medical Center, Northport, NY

    Northport, New York, 11768-2200, United States

  • Oklahoma City VA Medical Center, Oklahoma City, OK

    Oklahoma City, Oklahoma, 73104-5007, United States

  • Orlando VA Healthcare System, Orlando, FL

    Orlando, Florida, 32827, United States

  • Philadelphia MultiService Center, Philadelphia, PA

    Philadelphia, Pennsylvania, 19106, United States

  • Phoenix VA Health Care System, Phoenix, AZ

    Phoenix, Arizona, 85012, United States

  • Providence VA Medical Center, Providence, RI

    Providence, Rhode Island, 02908-4734, United States

  • Richard L. Roudebush VA Medical Center, Indianapolis, IN

    Indianapolis, Indiana, 46202-2884, United States

  • Richmond VA Medical Center, Richmond, VA

    Richmond, Virginia, 23249-0001, United States

  • Robley Rex VA Medical Center, Louisville, KY

    Louisville, Kentucky, 40206-1433, United States

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    Aurora, Colorado, 80045-7211, United States

  • Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC

    Salisbury, North Carolina, 28144, United States

  • St. Louis VA Medical Center John Cochran Division, St. Louis, MO

    St Louis, Missouri, 63106-1621, United States

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    Ann Arbor, Michigan, 48105-2303, United States

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    Boston, Massachusetts, 02130-4817, United States

  • VA Caribbean Healthcare System, San Juan, PR

    San Juan, 00927-3200, Puerto Rico

  • VA Central California Health Care System, Fresno, CA

    Fresno, California, 93703, United States

  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT

    West Haven, Connecticut, 06516-2770, United States

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    West Los Angeles, California, 90073-1003, United States

  • VA Loma Linda Healthcare System, Loma Linda, CA

    Loma Linda, California, 92357-1000, United States

  • VA Long Beach Healthcare System, Long Beach, CA

    Long Beach, California, 90822, United States

  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

    Dallas, Texas, 75216-7167, United States

  • VA Pacific Islands Health Care System, Honolulu, HI

    Honolulu, Hawaii, 96819-1522, United States

  • VA Portland Health Care System, Portland, OR

    Portland, Oregon, 97207-2964, United States

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

    Seattle, Washington, 98108-1532, United States

  • VA Salt Lake City Health Care System, Salt Lake City, UT

    Salt Lake City, Utah, 84148-0001, United States

  • VA San Diego Healthcare System, San Diego, CA

    San Diego, California, 92161-0002, United States

  • Washington DC VA Medical Center, Washington, DC

    Washington D.C., District of Columbia, 20422-0001, United States

  • White River Junction VA Medical Center, White River Junction, VT

    White River Junction, Vermont, 05001-3833, United States

  • William S. Middleton Memorial Veterans Hospital, Madison, WI

    Madison, Wisconsin, 53705-2254, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.