From Uncertainty to Evidence: A Randomized Controlled Trial for Optimal Surveillance in High-Risk Colonoscopy-Negative Individuals After Positive FIT
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,274
- 试验地点
- 1
- 主要终点
- Detection rate of advanced colorectal neoplasia (ACN)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •History of colorectal cancer
- •Inflammatory bowel disease
- •Known hereditary colorectal cancer syndrome
- •Life expectancy less than five years
- •Inability or unwillingness to undergo colonoscopy
研究组 & 干预措施
FIT Surveillance
Participants will undergo repeat fecal immunochemical testing two years after enrollment. Colonoscopy will only be recommended if the repeat FIT result is positive.
干预措施: Colonoscopy Surveillance (Diagnostic Test)
Colonoscopy Surveillance
Participants will undergo direct colonoscopy two years after enrollment regardless of FIT results.
干预措施: Colonoscopy Surveillance (Diagnostic Test)
结局指标
主要结局
Detection rate of advanced colorectal neoplasia (ACN)
时间窗: 2 years
ACN is defined as colorectal cancer or advanced adenoma (adenoma ≥10 mm, villous histology, or high-grade dysplasia).
次要结局
- 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)
研究者
National Taiwan University Clinical Trial Center
Visiting Staff
National Taiwan University Hospital