Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by VA Office of Research and Development
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01239082
First received: November 9, 2010
Last updated: August 25, 2016
Last verified: August 2016
  Purpose

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 Intervention
Colorectal Cancer
Procedure: Colonoscopy
Procedure: FIT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: CSP #577 - Colonoscopy vs. Fecal Immunochemical Testing in Reducing Mortality From Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • The primary outcome is colorectal cancer mortality. [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50000
Study Start Date: April 2012
Estimated Study Completion Date: September 2027
Estimated Primary Completion Date: September 2027 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01239082

Contacts
Contact: Beata Planeta, MS (203) 932-5711 ext 3791 Beata.Planeta@va.gov
Contact: Lynn M Tommessilli (203) 932-5711 ext 3769 Lynn.Tommessilli@va.gov

  Hide Study Locations
Locations
United States, Arizona
Phoenix VA Health Care System, Phoenix, AZ Recruiting
Phoenix, Arizona, United States, 85012
Contact: Young A Michele, MD    602-277-5551 ext 7940    Michele.Young2@va.gov   
United States, Arkansas
Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR Recruiting
Little Rock, Arkansas, United States, 72205-5484
Contact: Kurt H Hagedorn, MD    501-257-5950    kurt.hagedorn@va.gov   
United States, California
VA Central California Health Care System, Fresno, CA Recruiting
Fresno, California, United States, 93703
Contact: Helen W Wong, MD    559-225-6100 ext 5069    helen.wong@va.gov   
VA Loma Linda Healthcare System, Loma Linda, CA Recruiting
Loma Linda, California, United States, 92357
Contact: Christian S Jackson, MD    909-825-7084 ext 1184    christian.jackson@va.gov   
Contact: Ronald Fernando, MD    9095836201    Ronald.Fernando@va.gov   
VA Long Beach Healthcare System, Long Beach, CA Recruiting
Long Beach, California, United States, 90822
Contact: Mazen Jamal, MD    562-826-5628    mazen.jamal@va.gov   
Contact: Douglas Nguyen, MD    5628265848    Douglas.Nguyen@va.gov   
VA San Diego Healthcare System, San Diego, CA Recruiting
San Diego, California, United States, 92161
Contact: Samuel B Ho, MD    858-642-3280    samuel.ho2@va.gov   
Contact: Samir Gupta       Samir.Gupta@va.gov   
VA Greater Los Angeles Healthcare System, West Los Angeles, CA Recruiting
West Los Angeles, California, United States, 90073
Contact: Joseph R Pisegna, MD    310-268-3578    joseph.pisegna@va.gov   
United States, Colorado
VA Eastern Colorado Health Care System, Denver, CO Recruiting
Denver, Colorado, United States, 80220
Contact: Jed Olson, MD    303-399-8020 ext 3713    jed.olson@va.gov   
Contact: Swati Patel, MD    3033998020    swati.patel2@va.gov   
United States, Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT Recruiting
West Haven, Connecticut, United States, 06516
Contact: Petr Protiva, MD    203-932-5711 ext 2210    Petr.Protiva@va.gov   
United States, District of Columbia
Washington DC VA Medical Center, Washington, DC Recruiting
Washington, District of Columbia, United States, 20422
Contact: Michael D Yao, MD    202-745-8455    Michael.Yao2@va.gov   
United States, Florida
North Florida/South Georgia Veterans Health System, Gainesville, FL Recruiting
Gainesville, Florida, United States, 32608
Contact: Rebecca Beyth, MD    352-548-6000 ext 6895    Rebecca.Beyth@va.gov   
Miami VA Healthcare System, Miami, FL Recruiting
Miami, Florida, United States, 33125
Contact: Paul A Feldman, MD    305-575-7000 ext 3162    paul.feldman@va.gov   
Orlando VA Medical Center, Orlando, FL Active, not recruiting
Orlando, Florida, United States, 32803
James A. Haley Veterans' Hospital, Tampa, FL Recruiting
Tampa, Florida, United States, 33612
Contact: Jeffrey Gill, MD    813-972-2000 ext 6237    jeffrey.gill@va.gov   
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA Recruiting
Decatur, Georgia, United States, 30033
Contact: Goebel Stephan, MD    404-321-6111 ext 2781    stephan.goebel@va.gov   
United States, Hawaii
VA Pacific Islands Health Care System, Honolulu, HI Active, not recruiting
Honolulu, Hawaii, United States, 96819-1522
United States, Illinois
Jesse Brown VA Medical Center, Chicago, IL Active, not recruiting
Chicago, Illinois, United States, 60612
United States, Indiana
Richard L. Roudebush VA Medical Center, Indianapolis, IN Recruiting
Indianapolis, Indiana, United States, 46202-2884
Contact: Thomas F Imperiale, MD    317-988-2223    thomas.imperiale@va.gov   
Contact: Charles Kahi, MD    3179883682    Charles.Kahi@va.gov   
United States, Kentucky
Robley Rex VA Medical Center, Louisville, KY Not yet recruiting
Louisville, Kentucky, United States, 40206
Contact: Dipendra Parajuli, MD    502-287-4000 ext 56143    Dipendra.Parajuli@va.gov   
Contact: Endashaw Omer, MD    5022874000    Endashaw.Omer@va.gov   
United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD Recruiting
Baltimore, Maryland, United States, 21201
Contact: Erik von Rosenvinge, MD    410-605-7000 ext 5260    erik.vonrosenvinge@va.gov   
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Recruiting
Boston, Massachusetts, United States, 02130
Contact: Gyorgy Baffy, MD    857-364-4327    Gyorgy.Baffy@va.gov   
Contact: Ildiko Halasz, MD    6173237700 ext 35370    Ildiko.Halasz@va.gov   
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Philip Schoenfeld, MD    734-845-5795    philip.schoenfeld@va.gov   
Contact: Sameer Saini, MD    7348455865    Sameer.Saini@va.gov   
John D. Dingell VA Medical Center, Detroit, MI Recruiting
Detroit, Michigan, United States, 48201
Contact: Fadi Antaki, MD    313-576-3389    fadi.antaki@va.gov   
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Aasma Shaukat, MD    612-467-4100    aasma.shaukat@va.gov   
United States, Missouri
Kansas City VA Medical Center, Kansas City, MO Recruiting
Kansas City, Missouri, United States, 64128
Contact: Sharma Prateek, MD    818-861-4711 ext 56737    prateek.sharma@va.gov   
St. Louis VA Medical Center John Cochran Division, St. Louis, MO Recruiting
St Louis, Missouri, United States, 63106
Contact: Jill E Elwing, MD    314-289-6434    jill.elwing@va.gov   
United States, New Hampshire
Manchester VA Medical Center, Manchester, NH Recruiting
Manchester, New Hampshire, United States, 03104
Contact: Heiko Pohl, MD    802-295-9363 ext 5595    Heiko.Pohl@va.gov   
United States, New Jersey
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ Active, not recruiting
East Orange, New Jersey, United States, 07018
United States, New York
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY Withdrawn
New York, New York, United States, 10010
Northport VA Medical Center, Northport, NY Recruiting
Northport, New York, United States, 11768
Contact: Robert D Shaw, MD    631-261-4400 ext 2832    robert.shaw3@va.gov   
United States, North Carolina
Durham VA Medical Center, Durham, NC Active, not recruiting
Durham, North Carolina, United States, 27705
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC Active, not recruiting
Salisbury, North Carolina, United States, 28144
United States, Ohio
Louis Stokes VA Medical Center, Cleveland, OH Active, not recruiting
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Oklahoma City VA Medical Center, Oklahoma City, OK Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: William M Tierney, MD    405-456-1000    william.tierney@va.gov   
Contact: Mohammad Madhoun, MD    4054563260    Mohammad.Madhoun@va.gov   
United States, Oregon
VA Portland Health Care System, Portland, OR Recruiting
Portland, Oregon, United States, 97239
Contact: David Lieberman, MD    503-721-1062    david.lieberman@va.gov   
Contact: Nancy Ho, MD    5032208262 ext 52410    Nancy.Ho2@va.gov   
United States, Pennsylvania
Philadelphia MultiService Center, Philadelphia, PA Recruiting
Philadelphia, Pennsylvania, United States, 19106
Contact: Emily C Paulson, MD    215-823-5800 ext 6637    Emily.Paulson@va.gov   
United States, Rhode Island
Providence VA Medical Center, Providence, RI Recruiting
Providence, Rhode Island, United States, 02908
Contact: Kittichai Promrat, MD    401-273-7100 ext 2356    kittichai.promrat@va.gov   
United States, South Carolina
Wm. Jennings Bryan Dorn VA Medical Center, Columbia SC Withdrawn
Columbia, South Carolina, United States, 29209
United States, Tennessee
Memphis VA Medical Center, Memphis, TN Active, not recruiting
Memphis, Tennessee, United States, 38104
United States, Texas
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX Recruiting
Dallas, Texas, United States, 75216
Contact: William V Harford, MD    214-857-4132    william.harford@va.gov   
Michael E. DeBakey VA Medical Center, Houston, TX Recruiting
Houston, Texas, United States, 77030
Contact: Rhonda A Cole, MD    713-794-7274    rhonda.cole@va.gov   
United States, Utah
VA Salt Lake City Health Care System, Salt Lake City, UT Recruiting
Salt Lake City, Utah, United States, 84148
Contact: Amelia Underwood, MD    801-582-1565 ext 1976    amelia.underwood@va.gov   
Contact: Andrew Gawron    8015821565 ext 1236    Andrew.Gawron@va.gov   
United States, Vermont
White River Junction VA Medical Center and Regional Office, White River Junction, VT Recruiting
White River Junction, Vermont, United States, 05009-0001
Contact: Heiko Pohl, MD    802-295-9363 ext 5595    Heiko.Pohl@va.gov   
United States, Virginia
Hunter Holmes McGuire VA Medical Center, Richmond, VA Recruiting
Richmond, Virginia, United States, 23249
Contact: Mitchell Schubert, MD    804-675-5000 ext 4333    Mitchell.Schubert@va.gov   
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA Recruiting
Seattle, Washington, United States, 98108
Contact: Jason A Dominitz, MD MHS    206-764-2285    jason.dominitz@va.gov   
Contact: Douglas J Robertson, MD MPH    (802) 295-9363 ext 6062    Douglas.Robertson@va.gov   
Study Chair: Jason A. Dominitz, MD MHS         
United States, West Virginia
Clarksburg Louis A. Johnson VA Medical Center, Clarksburg, WV Recruiting
Clarksburg, West Virginia, United States, 26301
Contact: Riaz Cassim, MD    304-623-7617    riaz.cassim@va.gov   
United States, Wisconsin
William S. Middleton Memorial Veterans Hospital, Madison, WI Recruiting
Madison, Wisconsin, United States, 53705
Contact: Adnan Said, MD    608-213-4070 ext 17002    adnan.said@va.gov   
Puerto Rico
VA Caribbean Healthcare System, San Juan, PR Recruiting
San Juan, Puerto Rico, 00921
Contact: Doris H Toro, MD    787-641-3669    doris.toro@va.gov   
Contact: Priscilla Magno, MD    7876417582    Priscilla.Magno@va.gov   
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
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01239082     History of Changes
Other Study ID Numbers: 577 
Study First Received: November 9, 2010
Last Updated: August 25, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: 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

ClinicalTrials.gov processed this record on December 06, 2016