Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colo-rectal Cancer | Colon Neoplasm | PROBABILISTIC | 0.70 |
| Fecal Immunochemical Test | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colonoscopy Surveillance | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- FIT Surveillance
- description
- Participants will undergo repeat fecal immunochemical testing two years after enrollment. Colonoscopy will only be recommended if the repeat FIT result is positive.
- interventionNames
- Diagnostic Test: Colonoscopy Surveillance
- label
- Colonoscopy Surveillance
- description
- Participants will undergo direct colonoscopy two years after enrollment regardless of FIT results.
- interventionNames
- Diagnostic Test: Colonoscopy Surveillance
Primary outcomes (1)
- measure
- Detection rate of advanced colorectal neoplasia (ACN)
- timeFrame
- 2 years
- description
- ACN is defined as colorectal cancer or advanced adenoma (adenoma ≥10 mm, villous histology, or high-grade dysplasia).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available