NCT07470658

Optimal Surveillance Strategy After Positive FIT and Negative Colonoscopy

From Uncertainty to Evidence: A Randomized Controlled Trial for Optimal Surveillance in High-Risk Colonoscopy-Negative Individuals After Positive FIT

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 1,274 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 45 Years – 74 Years
• Healthy volunteers: Accepted

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.

Detailed description

In colorectal cancer screening programs based on fecal immunochemical testing (FIT), a subgroup of individuals presents with strongly positive FIT results but negative findings on subsequent high-quality colonoscopy. Despite the absence of detected adenomas or cancer, these individuals may remain at increased risk of colorectal cancer. Currently, there is no consensus guideline regarding the optimal follow-up strategy for this population. Some clinicians recommend repeat colonoscopy, while others prefer non-invasive monitoring using FIT. This pragmatic randomized controlled trial will compare two surveillance strategies: Repeat FIT testing two years after enrollment Direct colonoscopy two years after enrollment The primary objective is to compare the detection rate of advanced colorectal neoplasia (ACN) between the two strategies. The results of this study may help establish evidence-based surveillance guidelines for this high-risk population.

Conditions

• Advanced Colorectal Cancer
• Colo-rectal Cancer
• Fecal Immunochemical Test

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Colonoscopy Surveillance	Participants will undergo direct colonoscopy two years after enrollment regardless of FIT results.

Timeline

• Start date: 2026-03-10
• Primary completion: 2029-10-31
• Completion: 2029-10-31
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: Taiwan