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.
Inclusion Criteria:
Exclusion Criteria:
yuyanbo2000@126.com8618769783511
Participants with long-standing UC meeting high-risk criteria (disease duration \>8/10 years, PSC, family history, or prior neoplasia). All participants undergo a unified surveillance protocol: baseline data collection → fecal sample collection for FIT and FC testing → LCI colonoscopy within 4 weeks regardless of stool test results.
Fecal biOmarker Response Evaluation for Super-Early Efficacy in Ulcerative Colitis
Fecal Immunochemical Test for Post-polypectomy Surveillance to Reduce Unnecessary eNdoscopy
Fecal Noninvasive Biomarkers Oriented Control Versus Usual Care Strategy in Ulcerative Colitis
FIT Combining FC for Predicting MH and Histology Remission in UC
FIT and Fecal Calprotectin in Patients With Chronic Lower GI Symptoms
Predictive Efficacy of Fecal Calprotectin Assay by Magnetic Particle Chemiluminescence for Mucosal Healing in Moderate-to-Severe Ulcerative Colitis Patients Undergoing Initial Biologic Therapy(PRECAL)
Effectiveness of Fecal Immunnochemical Test and Colonoscopy Screening in Hong Kong
Pro-active Fecal Calprotectin Monitoring PROMOTE-UC