Colonoscopy or Fecal Occult Blood Test in Screening Healthy Participants for Colorectal Cancer (00-046)
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ClinicalTrials.gov Identifier: NCT00102011 |
Recruitment Status
:
Active, not recruiting
First Posted
: January 19, 2005
Last Update Posted
: September 14, 2017
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer | Procedure: annual screening Procedure: fecal occult blood test Procedure: screening colonoscopy Procedure: standard follow-up care | Phase 3 |
OBJECTIVES:
- 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.
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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.
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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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 4952 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Screening |
Official Title: | Colonoscopy Screening Trial |
Study Start Date : | May 2000 |
Estimated Primary Completion Date : | May 2018 |
Estimated Study Completion Date : | May 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: Study I- Arm I
Participants undergo baseline screening colonoscopy
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Procedure: screening colonoscopy
Patients undergo baseline screening colonoscopy
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Study I- Arm II
Participants receive standard care
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Procedure: fecal occult blood test
Participants undergo a baseline fecal occult blood test (FOBT)
Procedure: standard follow-up care
Standard care
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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.
|
Procedure: screening colonoscopy
Patients undergo baseline screening colonoscopy
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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.
|
Procedure: annual screening
Participants with negative baseline FOBT undergo FOBT annually for up to 4 years in the absence of a positive FOBT
Procedure: fecal occult blood test
Participants undergo a baseline fecal occult blood test (FOBT)
|
- 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 ]

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Ages Eligible for Study: | 40 Years to 69 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102011
United States, Louisiana | |
Feist-Weiller Cancer Center at Louisiana State University Health Sciences | |
Shreveport, Louisiana, United States, 71130-3932 | |
United States, Minnesota | |
Masonic Cancer Center at University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10065 | |
United States, Washington | |
Group Health Central Hospital | |
Seattle, Washington, United States, 98112 |
Study Chair: | Ann Zauber, PhD | Memorial Sloan Kettering Cancer Center |
Publications:
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00102011 History of Changes |
Other Study ID Numbers: |
00-046 MSKCC-00046A UMN-2003NT062 |
First Posted: | January 19, 2005 Key Record Dates |
Last Update Posted: | September 14, 2017 |
Last Verified: | September 2017 |
Keywords provided by Memorial Sloan Kettering Cancer Center:
colon cancer rectal cancer |
Additional relevant MeSH terms:
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |