Claudin-2 Immunostaining to Detect Active or Inactive Inflammation in IBD Biopsies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study compares a new Claudin-2 immunostaining method with standard histologic scoring systems for inflammatory activity in IBD. Researchers will assess how well Claudin-2 staining agrees with established scores such as Geboes, Nancy, Robarts, PICASSO, and SHMHS. Participants will be followed for one year to correlate staining results with clinical outcomes, biomarkers, hospitalizations, surgeries, and treatment changes. Analyses will be conducted at the Promoter center's Biostatistics laboratory using demographic and histologic data. The goal is to determine feasibility, accuracy, and potential prognostic value of Claudin-2 staining in guiding disease management.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Confirmed diagnosis of IBD

Exclusion Criteria:

Unconfirmed diagnosis of IBD

Where it's running

• Gastroenterology IRCCS San Donato Policlinic
  San Donato Milanese, Mi, Italy Recruiting

Study contacts

• Study coordinator: Vito Annese, Prof. PI
• Email: vitoannese1@gmail.com
• Phone: 0039 3388261812

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.