Colonoscopy or Fecal Occult Blood Test in Screening Healthy Participants for Colorectal Cancer

Part of paid clinical trials in Shreveport, Louisiana.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT00102011
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 69 Years
Healthy Volunteers
Accepted

Interventions

  • annual screening — PROCEDURE
    Participants with negative baseline FOBT undergo FOBT annually for up to 4 years in the absence of a positive FOBT
  • fecal occult blood test — PROCEDURE
    Participants undergo a baseline fecal occult blood test (FOBT)
  • screening colonoscopy — PROCEDURE
    Patients undergo baseline screening colonoscopy
  • standard follow-up care — PROCEDURE
    Standard care

Study Details

RATIONALE: Screening tests, such as colonoscopy and fecal occult blood test, may help doctors find tumor cells early and plan better treatment for colorectal cancer. PURPOSE: This randomized phase III trial is studying colonoscopy to see how well it works compared to fecal occult blood test in screening healthy participants for colorectal cancer.

Key Dates

Start date
May 25, 2000
Status verified
Mar 2026
Primary completion
Mar 5, 2026
Completion
Mar 5, 2026

Study Design

Enrollment
4,952 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Study I- Arm I
    Participants undergo baseline screening colonoscopy
  • Other: Study I- Arm II
    Participants receive standard care
  • Experimental: Study II- Arm I
    Participants undergo baseline screening colonoscopy. Participants are given individualized recommendations for further surveillance based on the results of the colonoscopy.
  • Active Comparator: Study II- Arm II
    Participants undergo a baseline fecal occult blood test (FOBT). Participants are given individualized recommendations for further surveillance based on the results of the FOBT. Participants with negative baseline FOBT undergo FOBT annually for up to 4 years in the absence of a positive FOBT.

Primary Outcome Measure

Neoplastic findings as assessed by screening colonoscopy vs annual fecal occult blood test (FOBT)-directed colonoscopy [ Time Frame: 5 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
Feist-Weiller Cancer Center at Louisiana State University Health SciencesShreveportLouisiana71130-3932-
Masonic Cancer Center at University of Minnesota (Data collection only)MinneapolisMinnesota55455-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
Kaiser Permanente Washington Health Research Institute (Data collection only)SeattleWashington98101-1466-

Find similar trials in Shreveport, LA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Feist-Weiller Cancer Center at Louisiana State University Health Sciences· Shreveport, LAMasonic Cancer Center at University of Minnesota (Data collection only)· Minneapolis, MNMemorial Sloan-Kettering Cancer Center· New York, NYKaiser Permanente Washington Health Research Institute (Data collection only)· Seattle, WA

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