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

ConditionsUlcerative Colitis (UC)Crohn Disease

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorIRCCS Policlinico S. Donato

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Consecutive patients with IBD recruited at the IBD Unit of the Gastroenterology Department of IRCCS San Donato POliclinic

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants

are grouped into 1 trial group

Group A: IBD patients

Trial outcomes

Primary outcomes

Active/inactive inflammation

Positive/negative Claudin staining

Time frame

At enrolement

Secondary outcomes

Outcomes

Number of episodes of relapse, hospitalization and surgery during 1 year of follow-up

Time frame

through study completion, an average of 1 year

Sponsors and contacts

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IRCCS Policlinico S. Donato

Lead sponsor

Asst Degli Spedali Civili Di Brescia

Collaborator

Source ClinicalTrials.gov

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