Inflammatory Bowel Disease Cohort in Nantes (CELESTE)

February 6, 2025 updated by: Nantes University Hospital

Cohorte Nantaise de Maladies Inflammatoires Chroniques Intestinales

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

360

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 Locations

  • France
      • Nantes, France
      • Nantes, France
        • Not yet recruiting
        • Clinique Jules Verne
        • Contact:
          • Mathurin FLAMANT, MD
      • Nantes, France
        • Not yet recruiting
        • Hôpital Privé du Confluent
        • Contact:
          • Caroline TRANG, MD

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

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

Description

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);

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who succeed in their therapeutic strategy
Time Frame: One year after inclusion
Determine the proportion of patients who succeed in their therapeutic strategy at one year
One year after inclusion

Collaborators and Investigators

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

Sponsor

Nantes University Hospital

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 4, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2031

Study Registration Dates

First Submitted

February 5, 2024

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Actual)

February 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC23_0467

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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