Evaluation of the Accuracy of Immunostaining of Claudin 2 to Detect Active or Inactive Inflammation in Endoscopic Biopsies of IBD

Recruiting now

Conditions studied: Ulcerative Colitis (UC), Crohn Disease

In brief

In view of the increasing evidence of the importance of mucosal healing as a combination of endoscopic and histologic healing, and the complexity and lack of complete agreement of the evaluation of histologic healing in IBD, the aim of this study will be to evaluate the accuracy of a new methodology, the immunostaining for Claudine 2 as compared to others standard well-accepted scoring for histologic activity in IBD. The aim is compare the accuracy of this methodology and in addition the correlation with outcomes (i.e. relapse, hospitalization, surgery).

Key facts

Study ID

NCT07710287

Run by

IRCCS Policlinico S. Donato

People needed

100

Starts

2025-02-14

Expected to finish

2027-09-01

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of IBD

You may not qualify if…

• Unconfirmed diagnosis of IBD

Where it is running

• Gastroenterology IRCCS San Donato Policlinic — San Donato Milanese, Mi, Italy (enrolling)

Full record on ClinicalTrials.gov

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