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

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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. Dominitz, Study Chair
    Douglas J. Robertson, MD MPH, Study Chair
    Robert F Wallace, ScD
    Ph: (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: 602-277-5551Ext. 7795
    Email: charles.beymer@va.gov

    Arkansas
    Little Rock

    Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR

    Kurt H Hagedorn, MD
    Ph: 501-257-5950
    Email: kurt.hagedorn@va.gov

    California
    Fresno

    Veterans Affairs Medical Center - Fresno

    Helen W Wong, MD
    Ph: 559-225-6100Ext. 5069
    Email: helen.wong@va.gov

    Loma Linda

    Veterans Affairs Medical Center - Loma Linda (Pettis)

    Christian S Jackson, MD
    Ph: 909-825-7084Ext. 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: 303-399-8020Ext. 3127
    Email: dennis.ahnen@va.gov

    Connecticut
    West Haven

    Veterans Affairs Medical Center - West Haven

    Petr Protiva, MD
    Ph: 203-932-5711Ext. 2210
    Email: Petr.Protiva@va.gov

    Florida
    Gainesville

    Veterans Affairs Medical Center - Gainesville

    Shahnaz Sultan, MD
    Ph: 352-376-1611Ext. 6574
    Email: shahnaz.sultan@va.gov

    Miami

    Veterans Affairs Medical Center - Miami

    Paul A Feldman, MD
    Ph: 305-575-7000Ext. 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: 813-972-2000Ext. 6237
    Email: jeffrey.gill@va.gov

    Georgia
    Decatur

    Veterans Affairs Medical Center - Atlanta (Decatur)

    Mohammad Wehbi, MD
    Ph: 404-321-6111Ext. 6782
    Email: mohammad.wehbi@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: 410-605-7000Ext. 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: 818-861-4711Ext. 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: 631-261-4400Ext. 2832
    Email: robert.shaw3@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 MultiService Center, Philadelphia, PA

    Emily C Paulson, MD
    Ph: 215-823-5800Ext. 6637
    Email: Emily.Paulson@va.gov

    Rhode Island
    Providence

    Veterans Affairs Medical Center - Providence

    Kittichai Promrat, MD
    Ph: 401-273-7100Ext. 2356
    Email: kittichai.promrat@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: 801-582-1565Ext. 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: 802-295-9363Ext. 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) 295-9363Ext. 6062
    Email: Douglas.Robertson@va.gov

    Jason A. Dominitz, MD MHS
    Study 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: 608-213-4070Ext. 17002
    Email: adnan.said@va.gov

    Puerto Rico

    San Juan

    VA Caribbean Healthcare System, San Juan, PR

    Doris H Toro, MD
    Ph: 787-641-3669
    Email: doris.toro@va.gov

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT01239082
    ClinicalTrials.gov processed this data on February 23, 2015

    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.