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

NCT07742410 | Not Yet Recruiting

• 1 other identifier: DETECT-UCAN-2026-07
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Ulcerative Colitis (UC)

Outcome Measures

Primary Outcomes (1)

• Diagnostic Performance of Combined FIT+FC for UCAN

  Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (LR+), and negative likelihood ratio (LR-) of combined FIT+FC testing (either positive defined as positive) for detecting UCAN, using LCI colonoscopy with histopathology as the reference standard.

  At time of colonoscopy (within 4 weeks after stool sample collection)

Secondary Outcomes (6)

• UCAN Detection Rate

  At time of colonoscopy

• Comprehensive completion rate of the joint screening process

  Week 4 LCI colonoscopy

• Patient Adherence

  Within 4 weeks after stool collection

• Patient Acceptability

  At 4-week follow-up

• Optimal Cut-off Values

  Week 52

Study Arms (1)

Long-standing Ulcerative Colitis High-risk Cohort

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with long-standing ulcerative colitis at high risk for UCAN, including those with disease duration \>10 years (E1/E2) or \>8 years (E3), those with primary sclerosing cholangitis (PSC), those with a first-degree family history of colorectal cancer, or those with a history of colorectal neoplasia resected.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• 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

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Yanbo Yu

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yan zhang

CONTACT

8618769783511; yuyanbo2000@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of medicine

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: August 3, 2026
• Study Start: July 23, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share