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

July 13, 2026 updated by: IRCCS Policlinico S. Donato

Histologic Healing in IBD: Comparison of "Standard" Scores With Expression of Claudin 2 and Impact on Outcomes

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).

Study Overview

Status

Recruiting

Conditions

Detailed Description

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 immunostaining for Claudine 2 as compared to others standard well-accepted scoring for histologic activity in IBD. The immunostaining of Claudin 2 in term of presence/absence will also be evaluated in view of the outcomes of the patients after 1 year of follow-up.

The primary objective of the study will be to compare the feasibility and accuracy of immunostaining with Claudin 2 against others standard frequently reported scoring of histology in IBD. The primary endpoint will be therefore the concordance of the immunostaining of Claudin 2 with the histologic healing as evaluated by the standard histologic scoring for IBD, namely Geboes, Nancy, Robarts, PICASSO, and SHMHS.

For secondary objectives all patient enrolled at baseline will be evaluated for 1 year of follow-up, with reporting of clinical activity, inflammatory biomarkers, need for hospitalization, need for surgery, need of escalation of therapy, in relation to the immunostaining of Claudin 2 (presence/absence) and the presence/absence of histologic activity as evaluated by the traditional histologic scores.

The data analysis will be performed at the Promoter center, by the laboratory of Biostatistics. Demographic, anamnestic histological and clinical data will be collected and analysed. Continuous data will be reported as mean ± standard deviation (SD) or median and interquartile range (IQR), as appropriate. Categorical data will be reported using frequencies and proportions. The normality hypothesis will be tested for continuous variables by visual inspection of the graph qq and with Shapiro-Wilks test. Correlations will be assessed according to Pearson R or Spearman Rho, depending on the distribution. The t-test or Wilcoxon rank sum test will be used to compare unpaired averages in normally or non-normally distributed variables, respectively. Fisher's exact test or chi-square test will be used to compare categorical data between groups.

To evaluate the concordance of histologic evaluation (active/remission) of different scoring system and Claudin 2 immunostaining, the Cohen's kapра (к) will be evaluated. Perfect agreement is evident when Cohen's kappa equals 1; a value of Cohen's kappa equal to zero suggests that the agreement is no better than that which would be obtained by chance alone. Although there is no formal scale, the following levels of agreement are often considered appropriate for judging the extent of the agreement: Poor if к< 0.00; Slight if 0.00 ≤ к≤ 0.20; Fair if 0.21 ≤ k ≤ 0.40; Moderate if 0.41 ≤ k ≤ 0.60; Substantial if 0.61 ≤ к ≤ 0.80; Almost perfect if k > 0.80. То evaluate for a possible systematic difference the McNemar's test will be applied with significance set at P<0.05. The different outcomes at 1-year according to different measures (active disease/relapse, remission, change of therapy, hospitalization and surgery) and as composite evaluation (remission + no change of therapy or hospitalization or surgery vs active/relapse ± change of therapy or hospitalization or surgery) will be evaluated with Kaplan Meier survival analysis. The difference in outcome will be also analyzed with multivariate analysis by considering also the clinical variables.

Using a PASS procedure Kappa Test for Agreement Between Two Raters, an estimated sample size of 100 patients achieves 80% power and a error of 5% to detect a true Cohen' Kappa value of 0,66 in a test of H: Карра = ко (where ko= 0.04) vs. H1: Kappa ≠ к0 when there are 2 categories with frequencies equal to 30% and 70%.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Mi
      • San Donato Milanese, Mi, Italy, 20097
        • Recruiting
        • Gastroenterology IRCCS San Donato Policlinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

Confirmed diagnosis of IBD

Exclusion Criteria:

Unconfirmed diagnosis of IBD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
IBD patients
Patients with ulcerative colitis and Crohn' disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Active/inactive inflammation
Time Frame: At enrolement
Positive/negative Claudin staining
At enrolement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcomes
Time Frame: through study completion, an average of 1 year
Number of episodes of relapse, hospitalization and surgery during 1 year of follow-up
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Donato

Collaborators

Asst Degli Spedali Civili Di Brescia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

June 17, 2026

First Submitted That Met QC Criteria

July 13, 2026

First Posted (Actual)

July 17, 2026

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CET 511-2024
  • Protocol Giuliani 2025 (Other Grant/Funding Number: Giuliani SPA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Privacy restriction

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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