Optimal Surveillance Strategy After Positive FIT and Negative Colonoscopy

NCT07470658 · tracked via the Priya Life Science Taiwan tracker

Sponsor

National Taiwan University Hospital

Phase

Observational

Started

2026-03-10

Last updated

2026-03-13

Condition(s) studied

Advanced Colorectal CancerColo-rectal CancerFecal Immunochemical Test

Investigational drug(s) / intervention(s)

Colonoscopy Surveillance

Colonoscopy Surveillance: Participants will undergo direct colonoscopy two years after enrollment regardless of FIT results.

Study 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.

Eligibility

Sex

ALL

Min age

45 Years

Max age

74 Years

Healthy volunteers

Accepted

Inclusion Criteria: * Age 45-74 years * Quantitative FIT result with fecal hemoglobin ≥100 µg/g within the past two years * Negative high-quality colonoscopy following the positive FIT result * Ability to provide written informed consent Exclusion Criteria: * History of colorectal cancer * Inflammatory bowel disease * Known hereditary colorectal cancer syndrome * Life expectancy less than five years * Inability or unwillingness to undergo colonoscopy

Primary outcome measure(s)

Detection rate of advanced colorectal neoplasia (ACN) — 2 years
ACN is defined as colorectal cancer or advanced adenoma (adenoma ≥10 mm, villous histology, or high-grade dysplasia).

Trial sites (1)

Facility	City	Region	Status
National Taiwan University Hospital	Taipei	Taiwan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07470658 on ClinicalTrials.gov ↗ ← All trials in Taiwan