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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedScreeningActive50 to 75Other577
NCT01239082

Trial Description

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%. 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 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.

The investigators propose to perform a, large, simple, multicenter, randomized, parallel group trial directly comparing screening colonoscopy with annual FIT screening in average risk individuals. Our 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. We 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.

Eligibility Criteria

Inclusion Criteria:

  • Male and female adults aged 50-75 years of age
  • 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
  • gFOBT or FIT in the past 10 months
  • 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
  • Likely inability to track the individual over time (e.g. no permanent address at the time of screening for study entry)

Trial Contact Information

Trial Lead Organizations/Sponsors

Department of Veterans Affairs - Central Office

Jason A. DominitzStudy Chair

Douglas J. Robertson, MD MPHStudy Chair

Robert F Wallace, ScDPh: (203) 932-5711 Ext.3776
  Email: robert.wallace3@va.gov

Trial Sites

U.S.A.
Arizona
  Phoenix
 Veterans Affairs Medical Center - Phoenix
 Charles H Beymer, MD Ph: 602-277-5551 Ext.7795
  Email: charles.beymer@va.gov
California
  Fresno
 Veterans Affairs Medical Center - Fresno
 Helen W Wong, MD Ph: 559-225-6100 Ext.5069
  Email: helen.wong@va.gov
  Loma Linda
 Veterans Affairs Medical Center - Loma Linda (Pettis)
 Christian S Jackson, MD Ph: 909-825-7084 Ext.1184
  Email: christian.jackson@va.gov
  Long Beach
 Veterans Affairs Medical Center - Long Beach
 Mazen Jamal, MD Ph: 562-826-5628
  Email: mazen.jamal@va.gov
  San Diego
 Veterans Affairs Medical Center - San Diego
 Samuel B Ho, MD Ph: 858-642-3280
  Email: samuel.ho2@va.gov
  West Los Angeles
 Veterans Affairs Medical Center - West Los Angeles
 Joseph R Pisegna, MD Ph: 310-268-3578
  Email: joseph.pisegna@va.gov
Colorado
  Denver
 Veterans Affairs Medical Center - Denver
 Dennis J Ahnen, MD Ph: 303-399-8020 Ext.3127
  Email: dennis.ahnen@va.gov
Connecticut
  West Haven
 Veterans Affairs Medical Center - West Haven
 Petr Protiva, MD Ph: 203-932-5711 Ext.2210
  Email: Petr.Protiva@va.gov
Florida
  Gainesville
 Veterans Affairs Medical Center - Gainesville
 Shahnaz Sultan, MD Ph: 352-376-1611 Ext.6574
  Email: shahnaz.sultan@va.gov
  Miami
 Veterans Affairs Medical Center - Miami
 Paul A Feldman, MD Ph: 305-575-7000 Ext.3162
  Email: paul.feldman@va.gov
  Orlando
 Veterans Affairs Medical Center - Orlando
 Christopher Lopez, MD Ph: 321-397-6643
  Email: christopher.lopez@va.gov
  Tampa
 Veterans Affairs Medical Center - Tampa
 Jeffrey Gill, MD Ph: 813-972-2000 Ext.6237
  Email: jeffrey.gill@va.gov
Georgia
  Decatur
 Veterans Affairs Medical Center - Atlanta (Decatur)
 Mohammad Wehbi, MD Ph: 404-321-6111 Ext.6782
  Email: mohammad.wehbi@va.gov
Hawaii
  Honolulu
 VA Pacific Islands Health Care System, Honolulu, HI
 Fernando V Ona, MD Ph: 808-433-0078
  Email: fernando.ona@va.gov
Illinois
  Chicago
 Veterans Affairs Medical Center - Chicago Westside Hospital
 Lyn Sue Kahng, MD Ph: 312-569-6193
  Email: lynsue.kahng@va.gov
Indiana
  Indianapolis
 Veterans Affairs Medical Center - Indianapolis
 Thomas F Imperiale, MD Ph: 317-988-2223
  Email: thomas.imperiale@va.gov
Maryland
  Baltimore
 Veterans Affairs Medical Center - Baltimore
 Erik von Rosenvinge, MD Ph: 410-605-7000 Ext.5260
  Email: erik.vonrosenvinge@va.gov
Massachusetts
  Boston
 Veterans Affairs Medical Center - Boston - Jamaica Plain
 Gyorgy Baffy, MD Ph: 857-364-4327
  Email: Gyorgy.Baffy@va.gov
Michigan
  Ann Arbor
 Veterans Affairs Medical Center - Ann Arbor
 Philip Schoenfeld, MD Ph: 734-845-5795
  Email: philip.schoenfeld@va.gov
  Detroit
 Veterans Affairs Medical Center - Detroit
 Fadi Antaki, MD Ph: 313-576-3389
  Email: fadi.antaki@va.gov
Minnesota
  Minneapolis
 Veterans Affairs Medical Center - Minneapolis
 Aasma Shaukat, MD Ph: 612-467-4100
  Email: aasma.shaukat@va.gov
Missouri
  Kansas City
 Veterans Affairs Medical Center - Kansas City
 Sharma Prateek, MD Ph: 818-861-4711 Ext.56737
  Email: prateek.sharma@va.gov
  St Louis
 St. Louis VA Medical Center John Cochran Division, St. Louis, MO
 Jill E Elwing, MD Ph: 314-289-6434
  Email: jill.elwing@va.gov
New York
  Northport
 Veterans Affairs Medical Center - Northport
 Robert D Shaw, MD Ph: 631-261-4400 Ext.2832
  Email: robert.shaw3@va.gov
North Carolina
  Durham
 Veterans Affairs Medical Center - Durham
 Deborah A Fisher, MD Ph: 919-286-2287
  Email: deborah.fisher3@va.gov
  Salisbury
 Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
 Frank R Pancotto, MD Ph: 704-638-9000 Ext.2806
  Email: Frank.Pancotto@va.gov
Ohio
  Cleveland
 Veterans Affairs Medical Center - Cleveland
 Katarina B Greer, MD Ph: 216-791-3800 Ext.4057
  Email: katarina.greer@va.gov
Oklahoma
  Oklahoma City
 Oklahoma City VA Medical Center, Oklahoma City, OK
 William M Tierney, MD Ph: 405-456-1000
  Email: william.tierney@va.gov
Oregon
  Portland
 Veterans Affairs Medical Center - Portland
 David Lieberman, MD Ph: 503-721-1062
  Email: david.lieberman@va.gov
Pennsylvania
  Philadelphia
 Philadelphia, OPC
 Martin Tobi, MD Ph: 215-823-4451
  Email: martin.tobi@va.gov
Rhode Island
  Providence
 Veterans Affairs Medical Center - Providence
 Kittichai Promrat, MD Ph: 401-273-7100 Ext.2356
  Email: kittichai.promrat@va.gov
Tennessee
  Memphis
 Veterans Affairs Medical Center - Memphis
 Claudio Tombazzi, MD Ph: 901-523-8990 Ext.6650
  Email: claudio.tombazzi@va.gov
Texas
  Dallas
 Veterans Affairs Medical Center - Dallas
 William V Harford, MD Ph: 214-857-4132
  Email: william.harford@va.gov
  Houston
 Veterans Affairs Medical Center - Houston
 Rhonda A Cole, MD Ph: 713-794-7274
  Email: rhonda.cole@va.gov
Utah
  Salt Lake City
 Veterans Affairs Medical Center - Salt Lake City
 Mae F Go, MD Ph: 801-582-1565 Ext.44833
  Email: mae.go@va.gov
Vermont
  White River Junction
 White River Junction VA Medical Center and Regional Office, White River Junction, VT
 Heiko Pohl, MD Ph: 802-295-9363 Ext.5595
  Email: Heiko.Pohl@va.gov
Virginia
  Richmond
 Hunter Holmes McGuire VA Medical Center, Richmond, VA
 Juan Diego Baltodano, MD Ph: 804-675-5021
  Email: juan.baltodano@va.gov
Washington
  Seattle
 Veterans Affairs Medical Center - Seattle
 Jason A Dominitz, MD MHS Ph: 206-764-2285
  Email: jason.dominitz@va.gov
 Douglas J Robertson, MD MPH Ph: (802) 295-9363 Ext.6062
  Email: Douglas.Robertson@va.gov
 Jason A. Dominitz, MD MHSStudy Chair
West Virginia
  Clarksburg
 Veterans Affairs Medical Center - Clarksburg
 Riaz Cassim, MD Ph: 304-623-7617
  Email: riaz.cassim@va.gov
Wisconsin
  Madison
 Veterans Affairs Medical Center - Madison
 Adnan Said, MD Ph: 608-213-4070 Ext.17002
  Email: adnan.said@va.gov

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01239082
ClinicalTrials.gov processed this data on October 23, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.