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Recruiting NCT06256393

Inflammatory Bowel Disease Cohort in Nantes

Observational Inflammatory Bowel Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Collection of biological samples.
Who it may be relevant to
Registry conditions: Inflammatory Bowel Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Cohorte Nantaise de Maladies Inflammatoires Chroniques Intestinales

Overview

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.

Interventions

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

Primary outcome measures

  • Proportion of patients who succeed in their therapeutic strategy [Time frame: One year after inclusion]

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);

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 3 centers
  • CHU de Nantes — Nantes
  • Clinique Jules Verne — Nantes
  • Hopital Privé du Confluent — Nantes

Identifiers

NCT: NCT06256393 · RC23_0467

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗