Inflammatory Bowel Disease Cohort in Nantes

NCT06256393 | Recruiting

• 1 other identifier: RC23_0467
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 3

Brief Summary

The CELESTE cohort will be a three-center prospective cohort associated with the creation of a biobank including Inflammatory Bowel Diseases (IBD) patients with active disease

Conditions

Inflammatory Bowel Diseases

Keywords

Crohn's disease; Ulcerative colitis; Cohort; Biocollection pathophysiology

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who succeed in their therapeutic strategy

  Determine the proportion of patients who succeed in their therapeutic strategy at one year

  One year after inclusion

Study Arms (1)

Patients

Patients of both sexes, over 18 years of age, with an established diagnosis of IBD (Crohn's desease, ulcerative colitis, unclassified IBD or chronic pouchitis) will be eligible for inclusion in a consultation to schedule surgery or colonoscopy for disease relapse (at diagnosis or prior to initiation of treatment), irrespective of treatment received

Other: Collection of biological samples

Interventions

Collection of biological samples OTHER

Collection of blood samples and intestinal biopsies during a surgery or colonoscopy for disease relapse

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

IBD patients who are immunomodulator-naive or refractory to one or more lines of immunosuppressive, biotherapy, or small molecule therapy

You may qualify if:

• Patients over 18 years of age;
• Patients with an established diagnosis of IBD: CD, UC, unclassified IBD or refractory chronic pouchitis;
• Patients with active disease requiring surgery or endoscopy, whether performed at diagnosis or prior to initiation of new therapy;
• Patients who have given written consent to participate in the study and to keep biological samples for research purposes

You may not qualify if:

• Patients refusing to participate in the cohort;
• Patients with a contraindication to general anaesthesia;
• Vulnerable patients (under court protection, curators, guardians);

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (3)

CHU de Nantes

Nantes, France

RECRUITING

Clinique Jules Verne

Nantes, France

NOT YET RECRUITING

Hopital Privé du Confluent

Nantes, France

NOT YET RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Central Study Contacts

Catherine Le Berre, MD

CONTACT

+33240083152; catherine.leberre@chu-nantes.fr

Study Design

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

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: February 4, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2031
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

FR (3)