NCT07742410Not yet recruiting
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
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
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 24 Jul 2026
- Start date
- 23 Jul 2026
- Primary completion date
- 31 Aug 2029
- Lead sponsor
- Qilu Hospital of Shandong University
- Diseases
- Ulcerative colitis
- NCT number
- NCT07742410
What you commit to
- Study type: Observational
- Planned participants: 250
- From 23 Jul 2026 to the primary completion date, 31 Aug 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking antiplatelet or anticoagulant medications (aspirin, warfarin, rivaroxaban, etc.).
Other illness
- 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.
- History of total or subtotal colectomy.
Other
- Pregnant or breastfeeding women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.