Advanced Colorectal Cancer, Colo-rectal Cancer, Fecal Immunochemical Test
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTColonoscopy Surveillance
Participants will undergo direct colonoscopy two years after enrollment regardless of FIT results.
Sponsors
National Taiwan University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 74 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame |
|---|---|
| Detection rate of any adenoma | 2 years |
| Detection rate of colorectal cancer | 2 years |
| Screening compliance rate | 2 years |
| Cost-effectiveness comparison between surveillance strategies | 2 years |
Countries
Taiwan
Outcome results
None listed