Clincosm LogoSign in Get a demo

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

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Active, not recruiting
CT.gov ID
NCT01239082
Collaborator
(none)
50,126
Enrollment
46
Locations
2
Arms
197
Anticipated Duration (Months)
1089.7
Patients Per Site
5.5
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Colonoscopy
  • Procedure: FIT
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50126 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 :
Apr 30, 2012
Anticipated Primary Completion Date :
Sep 29, 2028
Anticipated Study Completion Date :
Sep 29, 2028

Arms and Interventions

Arm Intervention/Treatment
Other: Arm 1

Colonoscopy (one time screening)

Procedure: Colonoscopy
One time screening Colonoscopy to screen for colorectal cancer
Other: Arm 2

FIT (annually)

Procedure: FIT
Annual FIT testing

Outcome Measures

Primary Outcome Measures

  1. The primary outcome is colorectal cancer mortality. [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Phoenix VA Health Care System, Phoenix, AZ Phoenix Arizona United States 85012
2 Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR Little Rock Arkansas United States 72205-5484
3 VA Central California Health Care System, Fresno, CA Fresno California United States 93703
4 VA Loma Linda Healthcare System, Loma Linda, CA Loma Linda California United States 92357
5 VA Long Beach Healthcare System, Long Beach, CA Long Beach California United States 90822
6 VA San Diego Healthcare System, San Diego, CA San Diego California United States 92161
7 VA Greater Los Angeles Healthcare System, West Los Angeles, CA West Los Angeles California United States 90073
8 VA Eastern Colorado Health Care System, Denver, CO Denver Colorado United States 80220
9 VA Connecticut Healthcare System West Haven Campus, West Haven, CT West Haven Connecticut United States 06516
10 Washington DC VA Medical Center, Washington, DC Washington District of Columbia United States 20422
11 North Florida/South Georgia Veterans Health System, Gainesville, FL Gainesville Florida United States 32608
12 Miami VA Healthcare System, Miami, FL Miami Florida United States 33125
13 Orlando VA Medical Center, Orlando, FL Orlando Florida United States 32803
14 James A. Haley Veterans' Hospital, Tampa, FL Tampa Florida United States 33612
15 Atlanta VA Medical and Rehab Center, Decatur, GA Decatur Georgia United States 30033
16 VA Pacific Islands Health Care System, Honolulu, HI Honolulu Hawaii United States 96819-1522
17 Jesse Brown VA Medical Center, Chicago, IL Chicago Illinois United States 60612
18 Richard L. Roudebush VA Medical Center, Indianapolis, IN Indianapolis Indiana United States 46202-2884
19 Robley Rex VA Medical Center, Louisville, KY Louisville Kentucky United States 40206
20 Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD Baltimore Maryland United States 21201
21 VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Boston Massachusetts United States 02130
22 VA Ann Arbor Healthcare System, Ann Arbor, MI Ann Arbor Michigan United States 48105
23 John D. Dingell VA Medical Center, Detroit, MI Detroit Michigan United States 48201
24 Minneapolis VA Health Care System, Minneapolis, MN Minneapolis Minnesota United States 55417
25 Kansas City VA Medical Center, Kansas City, MO Kansas City Missouri United States 64128
26 St. Louis VA Medical Center John Cochran Division, St. Louis, MO Saint Louis Missouri United States 63106
27 Manchester VA Medical Center, Manchester, NH Manchester New Hampshire United States 03104
28 East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ East Orange New Jersey United States 07018
29 Northport VA Medical Center, Northport, NY Northport New York United States 11768
30 Durham VA Medical Center, Durham, NC Durham North Carolina United States 27705
31 Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC Salisbury North Carolina United States 28144
32 Louis Stokes VA Medical Center, Cleveland, OH Cleveland Ohio United States 44106
33 Oklahoma City VA Medical Center, Oklahoma City, OK Oklahoma City Oklahoma United States 73104
34 VA Portland Health Care System, Portland, OR Portland Oregon United States 97239
35 Philadelphia MultiService Center, Philadelphia, PA Philadelphia Pennsylvania United States 19106
36 Providence VA Medical Center, Providence, RI Providence Rhode Island United States 02908
37 Memphis VA Medical Center, Memphis, TN Memphis Tennessee United States 38104
38 VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX Dallas Texas United States 75216
39 Michael E. DeBakey VA Medical Center, Houston, TX Houston Texas United States 77030
40 VA Salt Lake City Health Care System, Salt Lake City, UT Salt Lake City Utah United States 84148
41 White River Junction VA Medical Center and Regional Office, White River Junction, VT White River Junction Vermont United States 05009-0001
42 Hunter Holmes McGuire VA Medical Center, Richmond, VA Richmond Virginia United States 23249
43 VA Puget Sound Health Care System Seattle Division, Seattle, WA Seattle Washington United States 98108
44 Clarksburg Louis A. Johnson VA Medical Center, Clarksburg, WV Clarksburg West Virginia United States 26301
45 William S. Middleton Memorial Veterans Hospital, Madison, WI Madison Wisconsin United States 53705
46 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01239082
Other Study ID Numbers:
  • 577
First Posted:
Nov 11, 2010
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
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

Study Results

No Results Posted as of Mar 16, 2022