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NCT Number: NCT06256393

Inflammatory Bowel Disease Cohort in Nantes

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nantes, Nantes, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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);

Treatment and study plan

Collection of biological samples

Other

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

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Le Berre, MD

CONTACT

[email protected]

+33240083152

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Cohorte Nantaise de Maladies Inflammatoires Chroniques Intestinales

Acronym: CELESTE

Important dates

Study start
2025
Primary completion
2028
Study completion
2031
First posted
Feb 13, 2024
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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