Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-01-06 @ 2:59 PM
Study NCT ID:
NCT06256393
Status:
RECRUITING
Last Update Posted:
2025-02-10
First Post:
2024-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inflammatory Bowel Disease Cohort in Nantes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2031-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2024-02-05', 'studyFirstSubmitQcDate': '2024-02-05', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients who succeed in their therapeutic strategy', 'timeFrame': 'One year after inclusion', 'description': 'Determine the proportion of patients who succeed in their therapeutic strategy at one year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Crohn's disease", 'Ulcerative colitis', 'Cohort', 'Biocollection pathophysiology'], 'conditions': ['Inflammatory Bowel Diseases']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nIt 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'IBD patients who are immunomodulator-naive or refractory to one or more lines of immunosuppressive, biotherapy, or small molecule therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age;\n* Patients with an established diagnosis of IBD: CD, UC, unclassified IBD or refractory chronic pouchitis;\n* Patients with active disease requiring surgery or endoscopy, whether performed at diagnosis or prior to initiation of new therapy;\n* Patients who have given written consent to participate in the study and to keep biological samples for research purposes\n\nExclusion Criteria:\n\n* Patients refusing to participate in the cohort;\n* Patients with chronic inflammatory bowel disease quiescent at inclusion;\n* Patients with a contraindication to general anaesthesia;\n* Vulnerable patients (under court protection, curators, guardians);'}, 'identificationModule': {'nctId': 'NCT06256393', 'acronym': 'CELESTE', 'briefTitle': 'Inflammatory Bowel Disease Cohort in Nantes', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Cohorte Nantaise de Maladies Inflammatoires Chroniques Intestinales', 'orgStudyIdInfo': {'id': 'RC23_0467'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': "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", 'interventionNames': ['Other: Collection of biological samples']}], 'interventions': [{'name': 'Collection of biological samples', 'type': 'OTHER', 'description': 'Collection of blood samples and intestinal biopsies during a surgery or colonoscopy for disease relapse', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Catherine Le Berre, MD', 'role': 'CONTACT', 'email': 'catherine.leberre@chu-nantes.fr', 'phone': '+33240083152'}], 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nantes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathurin FLAMANT, MD', 'role': 'CONTACT'}], 'facility': 'Clinique Jules Verne', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nantes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Caroline TRANG, MD', 'role': 'CONTACT'}], 'facility': 'Hopital Privé du Confluent', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'centralContacts': [{'name': 'Catherine Le Berre, MD', 'role': 'CONTACT', 'email': 'catherine.leberre@chu-nantes.fr', 'phone': '+33240083152'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}