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CSP #577 - Colonoscopy vs. Fecal Immunochemical Testing in Reducing Mortality From Colorectal Cancer (CONFIRM)

50 Years
75 Years
Open (Enrolling)
Colorectal Cancer

Thank you

Trial Information

CSP #577 - Colonoscopy vs. Fecal Immunochemical Testing in Reducing Mortality From Colorectal Cancer (CONFIRM)

Inclusion Criteria:

- Male and female adults aged 50-75 years of age:

- Able to provide informed consent

- Veteran eligible for VA care

Exclusion Criteria:

- Symptoms of lower gastrointestinal tract disease warranting colonoscopic evaluation,

- 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

- 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 10 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 12 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, 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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

The primary outcome is colorectal cancer mortality.

Outcome Time Frame:

10 years

Safety Issue:


Principal Investigator

Jason A. Dominitz, MD MHS

Investigator Role:

Study Chair

Investigator Affiliation:

VA Puget Sound Health Care System


United States: Federal Government

Study ID:




Start Date:

April 2012

Completion Date:

March 2025

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms



VA Puget Sound Health Care System Seattle, Washington  98101
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Boston, Massachusetts  02130
VA Greater Los Angeles Healthcare System, West Los Angeles, CA West Los Angeles, California  90073
Durham VA Medical Center, Durham, NC Durham, North Carolina  27705
VA Loma Linda Healthcare System, Loma Linda, CA Loma Linda, California  92357
Louis Stokes VA Medical Center, Cleveland, OH Cleveland, Ohio  44106
Phoenix VA Health Care System Carl T. Hayden VA Medical Center, Phoenix, AZ Phoenix, Arizona  85012
VA Central California Health Care System, Fresno, CA Fresno, California  93703
VA Long Beach Healthcare System, Long Beach, CA Long Beach, California  90822
VA San Diego Healthcare System, San Diego, CA San Diego, California  92161
VA Eastern Colorado Health Care System, Denver, CO Denver, Colorado  80220
VA Connecticut Healthcare System West Haven Campus, West Haven, CT West Haven, Connecticut  06516
North Florida/South Georgia Veterans Health System, Gainesville, FL Gainesville, Florida  32608
Miami VA Healthcare System, Miami, FL Miami, Florida  33125
Orlando VA Medical Center, Orlando, FL Orlando, Florida  32803
James A. Haley Veterans' Hospital, Tampa, FL Tampa, Florida  33612
Atlanta VA Medical and Rehab Center, Decatur, GA Decatur, Georgia  30033
VA Pacific Islands Health Care System, Honolulu, HI Honolulu, Hawaii  96819-1522
Jesse Brown VA Medical Center, Chicago, IL Chicago, Illinois  60612
Richard L. Roudebush VA Medical Center, Indianapolis, IN Indianapolis, Indiana  46202-2884
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD Baltimore, Maryland  21201
VA Ann Arbor Healthcare System, Ann Arbor, MI Ann Arbor, Michigan  48113
John D. Dingell VA Medical Center, Detroit, MI Detroit, Michigan  48201
Minneapolis VA Health Care System, Minneapolis, MN Minneapolis, Minnesota  55417
Kansas City VA Medical Center, Kansas City, MO Kansas City, Missouri  64128
St. Louis VA Medical Center John Cochran Division, St. Louis, MO St Louis, Missouri  63106
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ East Orange, New Jersey  07018
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY New York, New York  10010
Northport VA Medical Center, Northport, NY Northport, New York  11768
Oklahoma City VA Medical Center, Oklahoma City, OK Oklahoma City, Oklahoma  73104
Portland VA Medical Center, Portland, OR Portland, Oregon  97201
Philadelphia, OPC Philadelphia, Pennsylvania  19106
Providence VA Medical Center, Providence, RI Providence, Rhode Island  02908
Wm. Jennings Bryan Dorn VA Medical Center, Columbia SC Columbia, South Carolina  29209
Memphis VA Medical Center, Memphis, TN Memphis, Tennessee  38104
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX Dallas, Texas  75216
Michael E. DeBakey VA Medical Center, Houston, TX Houston, Texas  77030
VA Salt Lake City Health Care System, Salt Lake City, UT Salt Lake City, Utah  84148
White River Junction VA Medical Center and Regional Office, White River Junction, VT White River Junction, Vermont  05009-0001
Hunter Holmes McGuire VA Medical Center, Richmond, VA Richmond, Virginia  23249
Clarksburg Louis A. Johnson VA Medical Center, Clarksburg, WV Clarksburg, West Virginia  26301
William S. Middleton Memorial Veterans Hospital, Madison, WI Madison, Wisconsin  53705
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC Salisbury, North Carolina  28144