NCT07710287

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started Feb 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Feb 2025Sep 2027

Study Start

First participant enrolled

February 14, 2025

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

July 17, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

June 17, 2026

Last Update Submit

July 13, 2026

Conditions

Ulcerative Colitis (UC)Crohn Disease

Keywords

Ulcerative colitisCrohn's diseaseHistologyMucosa healingClaudin

Outcome Measures

Primary Outcomes (1)

  • Active/inactive inflammation

    Positive/negative Claudin staining

    At enrolement

Secondary Outcomes (1)

  • Outcomes

    through study completion, an average of 1 year

Study Arms (1)

IBD patients

Patients with ulcerative colitis and Crohn' disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Confirmed diagnosis of IBD

You may not qualify if:

  • Unconfirmed diagnosis of IBD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastroenterology IRCCS San Donato Policlinic

San Donato Milanese, Mi, 20097, Italy

RECRUITING

Related Publications (2)

  • Bassotti G, Del Sordo R, Lanzarotto F, Mino S, Ricci C, Villanacci V. Claudin-2 simplifies histological assessment of activity/remission of ulcerative colitis in real-life daily practice. Eur J Gastroenterol Hepatol. 2025 Apr 1;37(4):409-413. doi: 10.1097/MEG.0000000000002938. Epub 2025 Feb 4.

    PMID: 39975995BACKGROUND

  • 4. Mosli M.H., Feagan B.G., Sandborn W.J., D'haens G., Behling C., Kaplan K., et al. Histologic evaluation of ulcerative colitis: A systematic review of disease activity indices. Inflamm. Bowel Dis. 2014;20:564-575. 5. Arkteg C.B., Wergeland Sørbye S., Buhl Riis L., Dalen S.M., Florholmen J., Goll R. Real-life evaluation of histologic scores for Ulcerative Colitis in remission. PLoS ONE. 2021;16:e0248224. 6. Pai R.K., Jairath V., Vande Casteele N., Rieder F., Parker C.E., Lauwers G.Y. The emerging role of histologic disease activity assessment in ulcerative colitis. Gastrointest. Endosc. 2018;88:887-898. 7. Chateau T., Feakins R., Marchal-Bressenot A., Magro F., Danese S., Peyrin-Biroulet L. Histological Remission in Ulcerative Colitis: Under the Microscope Is the Cure. Am. J. Gastroenterol. 2020;115:179-189.

    BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

2 oriented endoscopy biopsies taken at every colon segment and terminal ileum

MeSH Terms

Conditions

Colitis, UlcerativeCrohn Disease

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Central Study Contacts

Vito Annese, Prof. PI

CONTACT

0039 3388261812vitoannese1@gmail.com

Antonella Bianchi, Study coordinator

CONTACT

0039 025277antonella.bianchi2@gruopposandonato.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2026

First Posted

July 17, 2026

Study Start

February 14, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

July 17, 2026

Record last verified: 2026-06

Locations

IT(1)