Inflammatory Bowel Disease Cohort in Nantes

NCT ID: NCT06256393

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 360 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-04
• Study Completion Date: 2031-02-28

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

Detailed Description

The CELESTE cohort will be a prospective cohort of IBD patients followed up at Nantes University Hospital, Jules Verne Clinic (Nantes) and/or Confluent Private Hospital (Nantes). The multicentric nature of the cohort including a tertiary referral center and two secondary care centers is a major asset, enabling the enrolment of a broad spectrum of patients, from those naïve to any immunomodulatory treatment to those refractory to multiple biologic therapies.

It will be associated with a multi-omics biobank with the aim of identifying new cellular and molecular signatures of success of the therapeutic strategy at one year.

Conditions

Inflammatory Bowel Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Collection of biological samples

Intervention Type: OTHER

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

Interventions

Collection of biological samples

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Patients refusing to participate in the cohort;
• Patients with chronic inflammatory bowel disease quiescent at inclusion;
• Patients with a contraindication to general anaesthesia;
• Vulnerable patients (under court protection, curators, guardians);

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Nantes

Nantes, , France

Site Status: RECRUITING

Clinique Jules Verne

Nantes, , France

Site Status: NOT_YET_RECRUITING

Hopital Privé du Confluent

Nantes, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Catherine Le Berre, MD

Role: CONTACT

catherine.leberre@chu-nantes.fr

+33240083152

Facility Contacts

Catherine Le Berre, MD

Role: primary

catherine.leberre@chu-nantes.fr

+33240083152

Mathurin FLAMANT, MD

Role: primary

Caroline TRANG, MD

Role: primary

Other Identifiers

RC23_0467

Identifier Type: -

Identifier Source: org_study_id