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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 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2026-08-03

No results posted yet for this study

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)

Sponsors & Collaborators

  • Qilu Hospital of Shandong University (Qingdao)

    collaborator OTHER

  • Zaozhuang Municipal Hospital

    collaborator OTHER

  • Weifang Traditional Chinese Medicine Hospital

    collaborator OTHER

  • Linyi People's Hospital

    collaborator OTHER

  • Shouguang people's Hospital

    collaborator UNKNOWN

  • Qilu Hospital of Shandong University

    lead OTHER

Principal Investigators

  • Yanbo Yu · Qilu Hospital of Shandong University

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-23
Primary Completion
2029-08-31
Completion
2029-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07742410 on ClinicalTrials.gov