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
Observational · No treatment assigned · Sites not listed yet · Qilu Hospital of Shandong University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ulcerative Colitis (UC). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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);…
Plus 3 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 250 participants are expected to take part.
- Start date: 2026-07-23 (planned).
- Main results expected around 2029-08-31 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Diagnostic Performance of Combined FIT+FC for UCAN (At time of colonoscopy (within 4 weeks after stool sample collection))
In the researchers’ words
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 is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis (UC) |
| Lead sponsor | Qilu Hospital of Shandong University |
| Collaborators | Qilu Hospital of Shandong University (Qingdao); Zaozhuang Municipal Hospital; Weifang Traditional Chinese Medicine Hospital; Linyi People's Hospital; Shouguang People's Hospital |
| Enrollment | 250 (estimated) |
| Start date | 2026-07-23 |
| Primary completion (est.) | 2029-08-31 |
| First posted | 2026-08-03 |
| Last updated | 2026-08-03 |
| 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 |
| ClinicalTrials.gov ID | NCT07742410 |
Interventions
- None listed
Full eligibility criteria (from the record)
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.
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.