A Phase 3 interventional study of annual screening and fecal occult blood test in Colorectal Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 4 sites in United States. Open to participants aged 40 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 3, Interventional, and Screening
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.
OBJECTIVES:
OUTLINE: This is a randomized, two-part, multicenter study.
Participants are asked whether they are interested in participating in a randomized controlled trial of colorectal cancer screening.
Screening colonoscopy feasibility study I (accrual completed as of 12/14/2004): Participants who are interested in participating in a screening trial are randomized to 1 of 2 screening arms.
Screening colonoscopy feasibility study II: Participants who are interested in participating in a screening trial are randomized to 1 of 2 screening arms.
All participants are followed annually for up to 4 years.
PROJECTED ACCRUAL: A total of 1,402 participants (701 per screening arm) have been accrued for feasibility study I within 3 years (accrual completed as of 12/14/2004). An additional 3,550 participants (1,775 per screening arm) will be accrued for feasibility study II within 5 years.
5,598 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.
This study's planned enrollment of 4,952 is above the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 66 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Participants undergo baseline screening colonoscopy
Procedure: screening colonoscopy
Participants receive standard care
Procedure: fecal occult blood test · Procedure: standard follow-up care
Participants undergo baseline screening colonoscopy. Participants are given individualized recommendations for further surveillance based on the results of the colonoscopy.
Procedure: screening colonoscopy
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.
Procedure: annual screening · Procedure: fecal occult blood test
Participants with negative baseline FOBT undergo FOBT annually for up to 4 years in the absence of a positive FOBT
Participants undergo a baseline fecal occult blood test (FOBT)
Patients undergo baseline screening colonoscopy
Standard care
Neoplastic findings as assessed by screening colonoscopy vs annual fecal occult blood test (FOBT)-directed colonoscopy
Time frame: 5 years
Burden on endoscopic and clinical resources
Time frame: 5 years
Harms associated with screening colonoscopy vs annual FOBT-directed colonoscopy
Time frame: 5 years
Benefit-to-harm ration for screening colonoscopy vs annual FOBT-directed colonoscopy
Time frame: 5 years
Level of participation in screening with FOBT-directed colonoscopy vs a single colonoscopy
Time frame: 5 years
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Memorial Sloan Kettering Cancer Center