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Colorectal CancerCONFIRMNCT01239082

Colonoscopy Versus Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer (CONFIRM)

A study testing Colonoscopy and Fecal immunochemical test (FIT) in people with Colorectal Cancer, run by VA Office of Research and Development at 46 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Colorectal cancer (CRC) is currently the second most common cause of cancer death in the United States, and one of the most preventable cancers. It has been shown in several randomized controlled trials that screening using fecal occult blood testing (FOBT) reduces CRC mortality by 13-33%. Read more about this study

Who is it for?
Ages 50 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Colorectal Cancer
What is being tested?
Colonoscopy and Fecal immunochemical test (FIT)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50,126 participants
Where
46 sitesin 2 countries
Study dates
30 Apr 2012to 1 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Veteran
  • Able to provide informed consent

Who cannot join

  • 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:
Show all 22Show fewer
  • 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)

Trial locations and contacts

46 sites in 2 countries.

46 sites in 2 countries

United States45 sites

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    Ann Arbor, Michigan, 48105-2303

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    Aurora, Colorado, 80045-7211

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

    Baltimore, Maryland, 21201

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

    Boston, Massachusetts, 02130-4817

  • Jesse Brown VA Medical Center, Chicago, IL

    Chicago, Illinois, 60612

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

    Clarksburg, West Virginia, 26301-4155

  • Louis Stokes VA Medical Center, Cleveland, OH

    Cleveland, Ohio, 44106-1702

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

    Dallas, Texas, 75216-7167

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    Decatur, Georgia, 30033-4004

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

    Detroit, Michigan, 48201-1916

  • Durham VA Medical Center, Durham, NC

    Durham, North Carolina, 27705-3875

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

    East Orange, New Jersey, 07018

  • VA Central California Health Care System, Fresno, CA

    Fresno, California, 93703

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

    Gainesville, Florida, 32608-1135

  • VA Pacific Islands Health Care System, Honolulu, HI

    Honolulu, Hawaii, 96819-1522

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

    Houston, Texas, 77030-4211

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

    Indianapolis, Indiana, 46202-2884

  • Kansas City VA Medical Center, Kansas City, MO

    Kansas City, Missouri, 64128-2226

  • Central Arkansas Veterans Healthcare System, Little Rock, AR

    Little Rock, Arkansas, 72205

  • VA Loma Linda Healthcare System, Loma Linda, CA

    Loma Linda, California, 92357-1000

  • VA Long Beach Healthcare System, Long Beach, CA

    Long Beach, California, 90822

  • Robley Rex VA Medical Center, Louisville, KY

    Louisville, Kentucky, 40206-1433

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

    Madison, Wisconsin, 53705-2254

  • Manchester VA Medical Center, Manchester, NH

    Manchester, New Hampshire, 03104-7007

  • Memphis VA Medical Center, Memphis, TN

    Memphis, Tennessee, 38104-2127

  • Miami VA Healthcare System, Miami, FL

    Miami, Florida, 33125

  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis, Minnesota, 55417-2309

  • Northport VA Medical Center, Northport, NY

    Northport, New York, 11768-2200

  • Oklahoma City VA Medical Center, Oklahoma City, OK

    Oklahoma City, Oklahoma, 73104-5007

  • Orlando VA Healthcare System, Orlando, FL

    Orlando, Florida, 32827

  • Philadelphia MultiService Center, Philadelphia, PA

    Philadelphia, Pennsylvania, 19106

  • Phoenix VA Health Care System, Phoenix, AZ

    Phoenix, Arizona, 85012

  • VA Portland Health Care System, Portland, OR

    Portland, Oregon, 97207-2964

  • Providence VA Medical Center, Providence, RI

    Providence, Rhode Island, 02908-4734

  • Richmond VA Medical Center, Richmond, VA

    Richmond, Virginia, 23249-0001

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

    Salisbury, North Carolina, 28144

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

    Salt Lake City, Utah, 84148-0001

  • VA San Diego Healthcare System, San Diego, CA

    San Diego, California, 92161-0002

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

    Seattle, Washington, 98108-1532

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

    St Louis, Missouri, 63106-1621

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

    Tampa, Florida, 33612

  • Washington DC VA Medical Center, Washington, DC

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

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

    West Haven, Connecticut, 06516-2770

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

    West Los Angeles, California, 90073-1003

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

    White River Junction, Vermont, 05001-3833

Other trials in United States

Puerto Rico1 site

  • VA Caribbean Healthcare System, San Juan, PR

    San Juan, 00927-3200

Other trials in Puerto Rico

About this study

Official title: CSP #577 - Colonoscopy vs. Fecal Immunochemical Testing in Reducing Mortality From Colorectal Cancer

Colorectal cancer (CRC) is currently the second most common cause of cancer death in the United States, and one of the most preventable cancers. It has been shown in several randomized controlled trials that screening using fecal occult blood testing (FOBT) reduces CRC mortality by 13-33%. While there is strong consensus amongst experts regarding the value of CRC screening, the best approach to screening is not clear. Of the widely recommended modalities, FOBT and colonoscopy are the most commonly used within the United States. FOBT is inexpensive, non-invasive, and its use as a screening tool is supported by the highest quality evidence (i.e. randomized controlled trials). Moreover, newer FOBT, such as fecal immunochemical tests or fecal immunochemical tests (FITs), have advantages over conventional FOBT in terms of both test characteristics and ease of use that make them quite attractive as a population-based screening tool.

While colonoscopy is invasive and has higher up-front risks and costs than FOBT, it does afford the opportunity to directly assess the colonic mucosa and is widely believed to be the best test to detect colorectal cancer. In addition, colonoscopy allows for the detection and removal of colorectal adenomas -a well recognized colorectal cancer precursor. There is indirect evidence that suggests colonoscopy is effective in reducing colorectal cancer mortality, but to date, no large clinical trials have been completed to support this assumption. While colonoscopy use is increasing, data is emerging that colonoscopy may not be as effective as previously believed. Prior support for colonoscopy as a screening test relied upon effectiveness estimates that now appear to be overly optimistic. Given the invasive nature of colonoscopy, the associated small, but real risk of complications, and dramatically higher costs than other screening tests, it is especially important to determine the true comparative effectiveness of colonoscopy relative to other proven non-invasive options.

Read more

The investigators propose to perform a, large, simple, multicenter, randomized, parallel group trial directly comparing screening colonoscopy with annual fecal immunochemical test (FIT) screening in average risk individuals. The hypothesis is that colonoscopy will be superior to FIT in the prevention of colorectal cancer mortality measured over 10 years. Individuals will be enrolled if they are currently eligible for CRC screening (e.g. no colonoscopy in the past 10 years and no FOBT in the past 1 year) and are between 50 and 75 years of age. The investigators will exclude individuals for whom colonoscopy is indicated (e.g. signs or symptoms of CRC, first degree family member with CRC, personal history of colorectal neoplasia or inflammatory bowel disease).

All participants will complete baseline demographic, medication, and lifestyle questionnaires (e.g. diet, non-steroidal anti-inflammatory use, frequency of exercise) prior to randomization in a 1:1 ratio to either screening colonoscopy or annual FIT screening (Figure 1). Those testing positive by FIT will undergo evaluation to determine appropriateness for colonoscopy. Screening will be performed in a manner consistent with the currently accepted standard of care in order to determine the comparative effectiveness of the two screening strategies. Participants will be surveyed annually to determine if they have undergone colonoscopy or been diagnosed with CRC.

The primary study endpoint will be CRC mortality within 10 years of enrollment. The secondary endpoints are (1) the incidence of CRC within 10 years of enrollment and (2) major complications of colonoscopy. Mortality will be determined through queries of the VA Vital Status File. Cause of death will be determined primarily using death certificates from the National Death Index-Plus database, augmented by adjudication of medical records for known CRC cases where CRC is not listed as a cause of death on the death certificate. The investigators postulate that screening colonoscopy will result in a 40% reduction in CRC mortality over 10 years relative to annual FIT screening. Using a log-rank test with a 2-sided test of significance, =0.05, a sample size of 50,000 participants will be required to test the primary hypothesis with 82% power, assuming a 1% annual rate of crossover from FIT to colonoscopy and a 0.5% annual rate of loss to follow-up. The planned study duration is 12.5 years with 2.5 years of recruitment and 10 years of follow-up for all enrolled participants.

Being tested
Colonoscopy, Fecal immunochemical test (FIT)
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ColonoscopyProcedure or surgery

    One time screening Colonoscopy to screen for colorectal cancer

  • Fecal immunochemical test (FIT)Procedure or surgery

    Annual FIT testing

Study groups in NCT01239082
Study groupRoleWhat they receive
Arm 1OtherColonoscopy (one time screening)
Receives: Procedure: Colonoscopy
Arm 2OtherFIT (annually)
Receives: Procedure: Fecal immunochemical test (FIT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary outcome is colorectal cancer mortality.

    The primary outcome is colorectal cancer mortality. Patient survival will be monitored for 10 years, with survival assessed by both annual surveys and data reported to vital status registries, including the VA Vital Status File, which is comprised of the VA Beneficiary Identification and Records Locator System (BIRLS), the Medical SAS Inpatient Data Sets, and the Social Security Administration's Death Master File. The National Center for Health Statistics' National Death Index database will be used to find cause of death.

    Measured: 10 years

Secondary outcomes (1)

  1. Fecal immunochemical test (FIT) Positive - If Colonoscopy is Warranted

    There are no physical risks associated with performance of FIT screening. However, those with a positive FIT will be referred for evaluation by their primary care provider or site principal investigator to determine if colonoscopy is warranted. Those subsequently referred for colonoscopy will be exposed to its risks, and complications will be tracked as a secondary outcome measure

    Measured: 10 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2010 (estimated)
  2. Study start30 Apr 2012
  3. Primary completion1 Dec 2028 (estimated)
  4. Study completion1 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50,126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01239082
Sponsor's protocol ID
577
Acronym
CONFIRM
Status last verified
Aug 2026
First submitted
9 Nov 2010
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dominitz JA, Robertson DJ, Ahnen DJ, Allison JE, Antonelli M, Boardman KD, Ciarleglio M, Del Curto BJ, Huang GD, Imperiale TF, Larson MF, Lieberman D, O'Connor T, O'Leary TJ, Peduzzi P, Provenzale D, Shaukat A, Sultan S, Voorhees A, Wallace R, Guarino PD. Colonoscopy vs. Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer (CONFIRM): Rationale for Study Design. Am J Gastroenterol. 2017 Nov;112(11):1736-1746. doi: 10.1038/ajg.2017.286. Epub 2017 Oct 10.

    PubMed 29016565

  • Robertson DJ, Dominitz JA, Beed A, Boardman K, Del Curto BJ, Guarino PD, Huang GD, Imperiale TF, LaCasse A, Larson M, Gupta S, Lieberman D, Planeta B, O'Leary TJ, Shaukat A, Sultan S, Kyriakides TC; CONFIRM Study Group. Race, ethnicity, and prior colorectal screening test use in CONFIRM colonoscopy vs fecal immunochemical testing trial participants. JNCI Cancer Spectr. 2026 Aug 26:pkag080. doi: 10.1093/jncics/pkag080. Online ahead of print.

    PubMed 42644818

  • Robertson DJ, Dominitz JA, Beed A, Boardman KD, Del Curto BJ, Guarino PD, Imperiale TF, LaCasse A, Larson MF, Gupta S, Lieberman D, Planeta B, Shaukat A, Sultan S, Menees SB, Saini SD, Schoenfeld P, Goebel S, von Rosenvinge EC, Baffy G, Halasz I, Pedrosa MC, Kahng LS, Cassim R, Greer KB, Kinnard MF, Bhatt DB, Dunbar KB, Harford WV Jr, Mengshol JA, Olson JE, Patel SG, Antaki F, Fisher DA, Sullivan BA, Lenza C, Prajapati DN, Wong H, Beyth R, Lieb JG 2nd, Manlolo J, Ona FV, Cole RA, Khalaf N, Kahi CJ, Kohli DR, Rai T, Sharma P, Anastasiou J, Hagedorn C, Fernando RS, Jackson CS, Jamal MM, Lee RH, Merchant F, May FP, Pisegna JR, Omer E, Parajuli D, Said A, Nguyen TD, Tombazzi CR, Feldman PA, Jacob L, Koppelman RN, Lehenbauer KP, Desai DS, Madhoun MF, Tierney WM, Ho MQ, Hockman HJ, Lopez C, Carter Paulson E, Tobi M, Pinillos HL, Young M, Ho NC, Mascarenhas R, Promrat K, Mutha PR, Pandak WM Jr, Shah T, Schubert M, Pancotto FS, Gawron AJ, Underwood AE, Ho SB, Magno-Pagatzaurtundua P, Toro DH, Beymer CH, Kaz AM, Elwing J, Gill JA, Goldsmith SF, Yao MD, Protiva P, Pohl H, Kyriakides T; CONFIRM Study Group. Baseline Features and Reasons for Nonparticipation in the Colonoscopy Versus Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer (CONFIRM) Study, a Colorectal Cancer Screening Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2321730. doi: 10.1001/jamanetworkopen.2023.21730.

    PubMed 37432690

  • Shaukat A, Kahi CJ, Burke CA, Rabeneck L, Sauer BG, Rex DK. ACG Clinical Guidelines: Colorectal Cancer Screening 2021. Am J Gastroenterol. 2021 Mar 1;116(3):458-479. doi: 10.14309/ajg.0000000000001122.

    PubMed 33657038

Questions about this trial

What is this clinical trial studying?

A study testing Colonoscopy and Fecal immunochemical test (FIT) in people with Colorectal Cancer, run by VA Office of Research and Development at 46 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome is colorectal cancer mortality. (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01239082, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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