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

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ClinicalTrials.gov Identifier: NCT01239082
Recruitment Status : Active, not recruiting
First Posted : November 11, 2010
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: Colonoscopy Procedure: FIT Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: CSP #577 - Colonoscopy vs. Fecal Immunochemical Testing in Reducing Mortality From Colorectal Cancer
Actual Study Start Date : April 30, 2012
Estimated Primary Completion Date : September 29, 2028
Estimated Study Completion Date : September 29, 2028

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Arm 1
Colonoscopy (one time screening)
Procedure: Colonoscopy
One time screening Colonoscopy to screen for colorectal cancer
Arm 2
FIT (annually)
Procedure: FIT
Annual FIT testing



Primary Outcome Measures :
  1. The primary outcome is colorectal cancer mortality. [ Time Frame: 10 years ]
    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.


Secondary Outcome Measures :
  1. FIT Positive - If Colonoscopy is Warranted [ Time Frame: 10 Years ]
    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



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239082


  Hide Study Locations
Locations
United States, Arizona
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, United States, 85012
United States, Arkansas
Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR
Little Rock, Arkansas, United States, 72205-5484
United States, California
VA Central California Health Care System, Fresno, CA
Fresno, California, United States, 93703
VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, United States, 92357
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States, 90822
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073
United States, Colorado
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, United States, 80220
United States, Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States, 06516
United States, District of Columbia
Washington DC VA Medical Center, Washington, DC
Washington, District of Columbia, United States, 20422
United States, Florida
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States, 32608
Miami VA Healthcare System, Miami, FL
Miami, Florida, United States, 33125
Orlando VA Medical Center, Orlando, FL
Orlando, Florida, United States, 32803
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, United States, 33612
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033
United States, Hawaii
VA Pacific Islands Health Care System, Honolulu, HI
Honolulu, Hawaii, United States, 96819-1522
United States, Illinois
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, United States, 60612
United States, Indiana
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States, 46202-2884
United States, Kentucky
Robley Rex VA Medical Center, Louisville, KY
Louisville, Kentucky, United States, 40206
United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, United States, 48201
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417
United States, Missouri
Kansas City VA Medical Center, Kansas City, MO
Kansas City, Missouri, United States, 64128
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
Saint Louis, Missouri, United States, 63106
United States, New Hampshire
Manchester VA Medical Center, Manchester, NH
Manchester, New Hampshire, United States, 03104
United States, New Jersey
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
East Orange, New Jersey, United States, 07018
United States, New York
Northport VA Medical Center, Northport, NY
Northport, New York, United States, 11768
United States, North Carolina
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
Salisbury, North Carolina, United States, 28144
United States, Ohio
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Oklahoma City VA Medical Center, Oklahoma City, OK
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97239
United States, Pennsylvania
Philadelphia MultiService Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States, 19106
United States, Rhode Island
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, United States, 02908
United States, Tennessee
Memphis VA Medical Center, Memphis, TN
Memphis, Tennessee, United States, 38104
United States, Texas
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States, 75216
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030
United States, Utah
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States, 84148
United States, Vermont
White River Junction VA Medical Center and Regional Office, White River Junction, VT
White River Junction, Vermont, United States, 05009-0001
United States, Virginia
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, United States, 23249
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108
United States, West Virginia
Clarksburg Louis A. Johnson VA Medical Center, Clarksburg, WV
Clarksburg, West Virginia, United States, 26301
United States, Wisconsin
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, United States, 53705
Puerto Rico
VA Caribbean Healthcare System, San Juan, PR
San Juan, Puerto Rico, 00921
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Study Chair: Jason A. Dominitz, MD MHS VA Puget Sound Health Care System Seattle Division, Seattle, WA
Study Chair: Douglas J Robertson, MD MPH White River Junction VA Medical Center, White River Junction, VT

Publications of Results:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01239082     History of Changes
Other Study ID Numbers: 577
First Posted: November 11, 2010    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases