Inflammatory Bowel Disease Cohort in Nantes

Inflammatory Bowel Diseases Clinical Trial

— CELESTE  

Official title:

Cohorte Nantaise de Maladies Inflammatoires Chroniques Intestinales

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06256393
• Other study ID #: RC23_0467
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: March 2030

Study information

• Verified date: February 2024
• Source: Nantes University Hospital
• Contact: Catherine Le Berre, MD
• Phone: +33240083152
• Email: catherine.leberre[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: March 2030
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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);

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes
France	Clinique Jules Verne	Nantes
France	Hopital Privé du Confluent	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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