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.
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.
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.
Qilu Hospital of Shandong University
Lead sponsor
Qilu Hospital of Shandong University (Qingdao)
Collaborator
Zaozhuang Municipal Hospital
Collaborator
Weifang Traditional Chinese Medicine Hospital
Collaborator
Linyi People's Hospital
Collaborator
Shouguang people's Hospital
Collaborator