The Fecal Immunoassay Occult Blood Test Combined With Calprotectin Sequential Linkage Imaging Endoscopy Screening Strategy for Monitoring Tumor Changes Associated With Long-duration Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis (UC). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Primary outcome measures
- Diagnostic Performance of Combined FIT+FC for UCAN [Time frame: At time of colonoscopy (within 4 weeks after stool sample collection)]
Secondary outcome measures (6)
- UCAN Detection Rate [Time frame: At time of colonoscopy]
- Comprehensive completion rate of the joint screening process [Time frame: Week 4 LCI colonoscopy]
- Patient Adherence [Time frame: Within 4 weeks after stool collection]
- Patient Acceptability [Time frame: At 4-week follow-up]
- Optimal Cut-off Values [Time frame: Week 52]
- 12-Month Miss Rate [Time frame: 12 months after baseline]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07742410 · DETECT-UCAN-2026-07