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Optimal Surveillance Strategy After Positive FIT and Negative Colonoscopy
Sponsor: National Taiwan University Hospital
Summary
Individuals with high fecal hemoglobin concentrations detected by fecal immunochemical testing (FIT) but negative findings on high-quality colonoscopy represent a clinically challenging population. Although colonoscopy is considered the gold standard diagnostic procedure, previous studies suggest that these individuals may still have an elevated long-term risk of colorectal cancer. This randomized controlled trial aims to determine the optimal surveillance strategy for this high-risk group by comparing two approaches: repeat FIT testing after two years versus direct colonoscopy after two years.
Official title: From Uncertainty to Evidence: A Randomized Controlled Trial for Optimal Surveillance in High-Risk Colonoscopy-Negative Individuals After Positive FIT
Key Details
Gender
All
Age Range
45 Years - 74 Years
Study Type
OBSERVATIONAL
Enrollment
1274
Start Date
2026-03-10
Completion Date
2029-10-31
Last Updated
2026-03-13
Healthy Volunteers
Yes
Interventions
Colonoscopy Surveillance
Participants will undergo direct colonoscopy two years after enrollment regardless of FIT results.
Locations (1)
National Taiwan University Hospital
Taipei, Taiwan