Diagnostic Performance of Fecal Immunochemical Test Combined With Fecal Calprotectin Sequential Linked Color Imaging Endoscopy for Surveillance of Colitis-Associated Neoplasia in Long-standing Ulcerative Colitis: A Multicenter, Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 主要终点
- Diagnostic Performance of Combined FIT+FC for UCAN
研究概览
简要总结
Ulcerative colitis (UC) is a chronic inflammatory bowel disease associated with an increased risk of colorectal cancer, known as UC-associated neoplasia (UCAN). Current guidelines recommend regular colonoscopy surveillance for long-standing UC patients, but this strategy faces challenges including poor adherence and low neoplasia detection rates. This study aims to evaluate the diagnostic performance of a non-invasive pre-screening strategy combining fecal immunochemical test (FIT) and fecal calprotectin (FC), followed by linked color imaging (LCI) colonoscopy, for detecting UCAN in patients with long-standing UC.
This is a multicenter, prospective, diagnostic cohort study. Eligible patients with long-standing UC (disease duration >8 years for extensive colitis or >10 years for left-sided colitis, or with PSC) will undergo FIT and FC testing, followed by LCI colonoscopy within 4 weeks regardless of stool test results. The primary outcome is the diagnostic performance (sensitivity, specificity, PPV, NPV) of combined FIT+FC testing for UCAN, using LCI colonoscopy with histopathology as the reference standard. A total of 250 participants will be enrolled from 6 centers in China. Secondary outcomes include UCAN detection rate, feasibility indicators, patient adherence and acceptability, optimal cut-off values for FIT and FC, and 12-month miss rate.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years, any gender.
- •Definite diagnosis of ulcerative colitis by clinical, endoscopic, and pathological criteria.
- •Meeting at least one of the following high-risk criteria (with first onset of mucopurulent bloody stool as the starting time): E1/E2 disease duration >10 years; E3 disease duration >8 years; with primary sclerosing cholangitis (PSC); first-degree family history of colorectal cancer; history of colorectal neoplasia resected.
- •Discontinued any form of glucocorticoids for at least 4 weeks prior to enrollment.
- •In clinical remission at enrollment (stool frequency score <3, rectal bleeding score = 0).
- •Able to understand the study, voluntarily participate, and sign written informed consent.
排除标准
- •Presence of other gastrointestinal diseases or tumors.
- •Severe comorbidities (e.g., cardiopulmonary insufficiency, hepatic or renal failure) that may affect study results or preclude tolerance of endoscopy.
- •Currently taking antiplatelet or anticoagulant medications (aspirin, warfarin, rivaroxaban, etc.).
- •Pregnant or breastfeeding women.
- •History of total or subtotal colectomy.
结局指标
主要结局
Diagnostic Performance of Combined FIT+FC for UCAN
时间窗: At time of colonoscopy (within 4 weeks after stool sample collection)
Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (LR+), and negative likelihood ratio (LR-) of combined FIT+FC testing (either positive defined as positive) for detecting UCAN, using LCI colonoscopy with histopathology as the reference standard.
次要结局
- Patient Acceptability(At 4-week follow-up)
- UCAN Detection Rate(At time of colonoscopy)
- Comprehensive completion rate of the joint screening process(Week 4 LCI colonoscopy)
- Patient Adherence(Within 4 weeks after stool collection)
- Optimal Cut-off Values(Week 52)
- 12-Month Miss Rate(12 months after baseline)
研究者
Yan Zhang, MD
professor of medicine
Qilu Hospital of Shandong University