Colonoscopy or Fecal Occult Blood Test in Screening Healthy Participants for Colorectal Cancer
NCT ID: NCT00102011
Last Updated: 2025-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
4952 participants
INTERVENTIONAL
2000-05-31
2026-05-31
Brief Summary
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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.
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Detailed Description
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* Compare the neoplastic outcome of participants at average risk for colorectal cancer who undergo colonoscopy vs annual fecal occult blood tests.
* Compare the endoscopic and clinical resources required for these screening methods in these participants.
* Compare the benefit-to-harm ratio in participants undergoing these screening methods.
* Determine the level of participation of participants undergoing these screening methods.
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.
* Arm I: Participants undergo baseline screening colonoscopy.
* Arm II: Participants receive standard care.
* Screening colonoscopy feasibility study II: Participants who are interested in participating in a screening trial are randomized to 1 of 2 screening arms.
* Arm I: Participants undergo baseline screening colonoscopy. Participants are given individualized recommendations for further surveillance based on the results of the colonoscopy.
* 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.
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Study I- Arm I
Participants undergo baseline screening colonoscopy
screening colonoscopy
Patients undergo baseline screening colonoscopy
Study I- Arm II
Participants receive standard care
fecal occult blood test
Participants undergo a baseline fecal occult blood test (FOBT)
standard follow-up care
Standard care
Study II- Arm I
Participants undergo baseline screening colonoscopy. Participants are given individualized recommendations for further surveillance based on the results of the colonoscopy.
screening colonoscopy
Patients undergo baseline screening colonoscopy
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.
annual screening
Participants with negative baseline FOBT undergo FOBT annually for up to 4 years in the absence of a positive FOBT
fecal occult blood test
Participants undergo a baseline fecal occult blood test (FOBT)
Interventions
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annual screening
Participants with negative baseline FOBT undergo FOBT annually for up to 4 years in the absence of a positive FOBT
fecal occult blood test
Participants undergo a baseline fecal occult blood test (FOBT)
screening colonoscopy
Patients undergo baseline screening colonoscopy
standard follow-up care
Standard care
Eligibility Criteria
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Inclusion Criteria
* Healthy participants at average risk for developing colorectal cancer
* No history of colorectal cancer
* No history of familial adenomatous polyposis
* More than 5 years since prior flexible sigmoidoscopy
* No prior colonoscopy
PATIENT CHARACTERISTICS:
Age
* 50 to 69 (40 to 69 at the Louisiana State University participating site)
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Cardiovascular
* No myocardial infarction within the past year
* No congestive heart failure
Pulmonary
* No chronic obstructive pulmonary disease
Gastrointestinal
* No history of ulcerative colitis
* No history of Crohn's disease
* No history of inflammatory bowel disease
Other
* No serious comorbid condition
* No consumption of red meat within 3 days prior to and during FOBT (feasibility study II, arm II only)
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No concurrent chemotherapy other than for nonmelanoma skin cancer
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No vitamin C consumption \> 250 mg within 3 days prior to and during fecal occult blood testing (FOBT) (feasibility study II arm II only)
* No nonsteroidal anti-inflammatory drugs within 7 days prior to and during FOBT (feasibility study II, arm II only)
* No concurrent anticoagulants
* No concurrent anticancer therapy except for treatment of nonmelanoma skin cancer
40 Years
69 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Ann Zauber, PhD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Locations
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Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, United States
Masonic Cancer Center at University of Minnesota (Data collection only)
Minneapolis, Minnesota, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Kaiser Permanente Washington Health Research Institute (Data collection only)
Seattle, Washington, United States
Countries
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References
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Shaukat A, Church TR, Shanley R, Kauff ND, O'Brien MJ, Mills GM, Jordan PA, Allen JA, Kim A, Feld AD, Zauber AG, Winawer SJ. Development and validation of a clinical score for predicting risk of adenoma at screening colonoscopy. Cancer Epidemiol Biomarkers Prev. 2015 Jun;24(6):913-20. doi: 10.1158/1055-9965.EPI-14-1321. Epub 2015 Mar 23.
Mendelsohn RB, Winawer SJ, Jammula A, Mills G, Jordan P, O'Brien MJ, Close GM, Dorfman M, Church TR, Mandelson MT, Allen J, Feld A, Kauff ND, Morgan GA, Kumar JMR, Serrano V, Bayuga-Miller S, Fischer SE, Kuk D, Zauber AG. Adenoma Prevalence in Blacks and Whites Having Equal Adherence To Screening Colonoscopy: The National Colonoscopy Study. Clin Gastroenterol Hepatol. 2017 Sep;15(9):1469-1470. doi: 10.1016/j.cgh.2017.04.014. Epub 2017 Apr 15. No abstract available.
Zauber AG, Winawer SJ, O'Brien MJ, Mills GM, Allen JI, Feld AD, Jordan PA, Fleisher M, Orlow I, Meester RGS, Lansdorp-Vogelaar I, Rutter CM, Knudsen AB, Mandelson M, Shaukat A, Mendelsohn RB, Hahn AI, Lobaugh SM, Soto Palmer B, Serrano V, Kumar JR, Fischer SE, Chen JC, Bayuga-Miller S, Kuk D, O'Connell K, Church TR. Randomized Trial of Facilitated Adherence to Screening Colonoscopy vs Sequential Fecal-Based Blood Test. Gastroenterology. 2023 Jul;165(1):252-266. doi: 10.1053/j.gastro.2023.03.206. Epub 2023 Mar 21.
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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MSKCC-00046A
Identifier Type: -
Identifier Source: secondary_id
UMN-2003NT062
Identifier Type: -
Identifier Source: secondary_id
00-046
Identifier Type: -
Identifier Source: org_study_id
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