Screening Tests in Detecting Colorectal Cancer
RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for colorectal cancer.
PURPOSE: Randomized screening trial to compare the effectiveness of fecal occult blood testing with that of DNA-based testing of stool and blood in identifying colorectal cancer.
Other: physiologic testing
Procedure: comparison of screening methods
Procedure: fecal occult blood test
Procedure: screening colonoscopy
|Study Design:||Allocation: Randomized
Primary Purpose: Screening
|Official Title:||Colorectal Cancer Screening: Fecal Blood vs. DNA|
|Study Start Date:||October 2001|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
- Compare the performance characteristics (sensitivity, specificity, and predictive values) of fecal occult blood (FOB) testing and multitarget DNA-based assay panel (MTAP) testing applied to stools and plasma in identifying colorectal cancer.
- Compare the specificity of the MTAP and FOB tests in participants given pretest dietary restrictions vs no pretest dietary restrictions in order to evaluate the necessity of a formal pretest preparation for MTAP.
- Compare the detection rates of colorectal neoplasia using MTAP alone, flexible sigmoidoscopy alone, and combination sigmoidoscopy and FOB testing.
- Determine the causes of MTAP "false-positive" results, (i.e., positive MTAP and negative colonoscopy).
- Determine and compare the pathological and molecular features of colorectal cancer detected vs not detected by the MTAP.
OUTLINE: This is a randomized, multicenter study. Participants are stratified according to age (50-64 [closed to accrual as of 6/5/03] vs 65-80), gender (male vs female), and participating center. Participants are randomized to one of two screening arms.
- Arm I: Participants eat no red meat and take no nonsteroidal anti-inflammatory drugs (NSAIDs) and no vitamin C or multivitamins for 3 days prior to and during stool sample collection. Participants collect stool samples 3 different times and perform fecal occult blood (FOB) test smears from each stool. After each collection, participants ship the whole stool and FOB test smear to their participating center for blinded multitarget DNA-based assay panel (MTAP) testing.
- Arm II: Participants take no vitamin C or multivitamins for 3 days before and during stool sample collection. Participants collect stool samples and FOB test smears and samples are tested as in arm I.
Within 2 months after stool sample collection, participants have their blood drawn for additional MTAP testing and undergo colonoscopy.
PROJECTED ACCRUAL: A total of 4,000 participants (2,000 per arm) will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025025
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|Study Chair:||David A. Ahlquist, MD||Mayo Clinic|