NCT07470658Enrolling by invitation
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
Source: ClinicalTrials.gov · Last updated 13 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 1274 (estimated)
- First submitted
- 10 Mar 2026
- Start date
- 10 Mar 2026
- Primary completion date
- 31 Oct 2029
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07470658
What you commit to
- Study type: Observational
- Planned participants: 1274
- From 10 Mar 2026 to the primary completion date, 31 Oct 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of colorectal cancer
- Inflammatory bowel disease
- Known hereditary colorectal cancer syndrome
Other
- Life expectancy less than five years
- Inability or unwillingness to undergo colonoscopy
Who the study is looking for
- 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
Age in the registry: 45 years to 74 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.