ClinicalTrials.gov
Cure8 trial brief
Why This Matters
Patients and clinicians care about objective, reliable ways to tell if intestinal inflammation is truly healed because histologic healing predicts outcomes.
If Claudin‑2 immunostaining reliably indicates active vs inactive disease, it could simplify or improve histology assessment and better predict relapse or need for escalation.
Who Should Pay Attention
Adult IBD patients; gastroenterologists, pathologists, and IBD researchers interested in biomarkers and histologic healing.
Study Snapshot
Story typeClinical Reference
Evidence typeClinical trial
Enrollment100 participants
Study statusRecruiting
Source depthTrial registry record
What To Know
This is a registered, recruiting observational clinical study (NCT07710287) testing whether immunostaining for Claudin‑2 on endoscopic biopsy samples can accurately distinguish active versus inactive histologic inflammation in patients with ulcerative colitis or Crohn’s disease.
The trial will compare Claudin‑2 staining (presence/absence) against several established histologic scoring systems (Geboes, Nancy, Robarts, PICASSO, SHMHS) and follow enrolled patients for 1 year to look at clinical outcomes (relapse, hospitalization, surgery, therapy escalation).
The study plans to enroll about 100 adult IBD patients and will analyze concordance using Cohen’s kappa and relate Claudin‑2 results to biomarkers and clinical events using survival and multivariable analyses. Data will be collected at a single center (IRCCS Policlinico S. Donato, Italy) and analyzed by the promoter’s biostatistics lab.
This record describes study design, endpoints, and planned analyses; it does not report results or test performance. It focuses on a potential biomarker (Claudin‑2) for histologic activity rather than a treatment intervention.
Keep In Mind
Registry entry for a recruiting observational study; no results reported here. The record outlines planned analyses and a 1‑year follow‑up for clinical outcomes. Interpret as a trial description, not evidence of efficacy.
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
SponsorIRCCS Policlinico S. Donato
Trial IDNCT07710287
Study typeObservational
Enrollment100 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedJul 17, 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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