ClinicalTrials.gov
Cure8 trial brief
Why This Matters
This study could validate a noninvasive stool-test strategy (FIT + fecal calprotectin) to triage which long-standing UC patients need colonoscopy, potentially improving surveillance efficiency and adherence.
Who Should Pay Attention
Adults with long-standing UC or other high-risk features, gastroenterologists, and researchers focused on biomarkers and colorectal neoplasia surveillance.
Study Snapshot
Story typeClinical Reference
Evidence typeClinical trial
Enrollment250 participants
Study statusNot_yet_recruiting
Source depthTrial registry record
What To Know
This is a multicenter, prospective observational diagnostic study planned to enroll 250 adults with long-duration or otherwise high‑risk UC. Participants provide stool for FIT and fecal calprotectin (FC) testing and then undergo LCI colonoscopy with biopsy within 4 weeks regardless of stool results.
The study will measure sensitivity, specificity, PPV/NPV, and other performance metrics of combined FIT+FC against LCI colonoscopy plus histopathology as the reference. The study is currently listed as not yet recruiting and is being conducted at multiple centers in China.
Key secondary outcomes include detection rates, feasibility, adherence, optimal FIT/FC cutoffs, and a 12‑month miss rate.
Keep In Mind
This is a trial-record (observational diagnostic cohort) listed as NOT_YET_RECRUITING on ClinicalTrials.gov; the registry describes the planned design and outcomes but does not report results.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorQilu Hospital of Shandong University
Trial IDNCT07742410
Study typeObservational
Enrollment250 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedAug 3, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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