Optimal Surveillance Strategy After Positive FIT and Negative Colonoscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Colonoscopy Surveillance.
- Who it may be relevant to
- Registry conditions: Advanced Colorectal Cancer, Colo-rectal Cancer, Fecal Immunochemical Test. Basic parameters: 45 years — 74 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
From Uncertainty to Evidence: A Randomized Controlled Trial for Optimal Surveillance in High-Risk Colonoscopy-Negative Individuals After Positive FIT
Overview
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.
Interventions
- Diagnostic test Colonoscopy Surveillance
Participants will undergo direct colonoscopy two years after enrollment regardless of FIT results.
Primary outcome measures
- Detection rate of advanced colorectal neoplasia (ACN) [Time frame: 2 years]
Secondary outcome measures (4)
- Detection rate of any adenoma [Time frame: 2 years]
- Detection rate of colorectal cancer [Time frame: 2 years]
- Screening compliance rate [Time frame: 2 years]
- Cost-effectiveness comparison between surveillance strategies [Time frame: 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT07470658 · 202508171RINA