Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-26 @ 12:35 AM
Study NCT ID:
NCT06514092
Status:
RECRUITING
Last Update Posted:
2025-01-08
First Post:
2024-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Long-Term Risk of Recurrence of Anoperineal Fistula in Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 81}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2024-07-11', 'studyFirstSubmitQcDate': '2024-07-17', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long-term recurrence-free survival rate of perianal fistulas', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'To evaluate the long-term recurrence-free survival rate of perianal fistulas after combined treatment with anti-TNF alpha and seton drainage'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['perianal fistula', 'anti-TNF', 'seton drainage', 'inflammatory bowel disease'], 'conditions': ['Crohn Disease']}, 'descriptionModule': {'briefSummary': "This research aims to evaluate the long-term recurrence risk of perianal fistulas in Crohn's disease patients who have undergone treatment with anti-TNF therapy and seton drainage.The research seeks to identify factors influencing recurrence and assess the long term effectiveness of these treatments in preventing fistula recurrence. This study will provide insights that could enhance treatment strategies and improve patient outcomes.", 'detailedDescription': "Scientific Justification :\n\n● Perianal fistulas are a common and challenging complication of Crohn's disease, significantly impacting patient quality of life. Infliximab, an TNFα antagonist has shown its efficacy in inducing remission of these fistulas. Seton drainage is often used alongside anti-TNF therapy to promote fistula healing and prevent abscess formation. However, data with long term follow up are still lacking on the impact of these treatments. Understanding the long-term outcomes of these combined treatments is crucial for optimizing therapeutic strategies and improving patient management.\n\nTreatment Strategy :\n\n● The treatment involves administering infliximab to control inflammation and promote fistula closure, along with seton drainage to maintain fistula patency and prevent abscesses, ensuring continuous drainage and reducing infection risk.\n\nFollow-up Description :\n\n● Patients are monitored retrospectively through medical records for a period ranging from several months to years, assessing recurrence rates and potential predictors of recurrence. Follow-up includes regular clinical evaluations, biological evaluations (blood test and fecal calprotectin), colonoscopy, imaging studies such as MRI, and patient-reported outcomes to gather comprehensive data on the long-term efficacy and safety of the combined treatment approach."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "patients with crohn's disease", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed diagnosis of Crohn's disease\n* drainage of an anal fistula with seton combined with the initiation of anti-TNF alpha treatment\n* Patient who was treated in the digestive center of the Toulouse University Hospital for drainage of an anal fistula between January 1, 2000 and December 31, 2010\n\nExclusion Criteria:\n\nPatient followed less than 6 months after seton drainage"}, 'identificationModule': {'nctId': 'NCT06514092', 'acronym': 'LT-SAFCD', 'briefTitle': "Study on the Long-Term Risk of Recurrence of Anoperineal Fistula in Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': "Study on the Long-Term Risk of Recurrence of Anoperineal Fistula After Treatment with Anti-tumor Necrosis Factor (TNF) and Seton Drainage in Crohn's Disease : LT-SAFCD", 'orgStudyIdInfo': {'id': 'RC31/24/0174'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Crohn's patients", 'interventionNames': ['Other: anti-TNF therapy and seton drainage']}], 'interventions': [{'name': 'anti-TNF therapy and seton drainage', 'type': 'OTHER', 'description': "Crohn's disease patients who have undergone treatment with anti-TNF therapy and seton drainage.", 'armGroupLabels': ["Crohn's patients"]}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume LE COSQUER', 'role': 'CONTACT', 'email': 'lecosquer.g@chu-toulouse.fr'}, {'name': 'Tevin POLYNICE', 'role': 'CONTACT', 'email': 'polynice.t@chu-toulouse.fr'}, {'name': 'Guillaume LE COSQUER', 'role': 'CONTACT'}], 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Guillaume LE COSQUER, MD', 'role': 'CONTACT', 'email': 'lecosquer.g@chu-toulouse.fr', 'phone': '05 61 32 20 45', 'phoneExt': '+33'}, {'name': 'Tevin POLYNICE', 'role': 'CONTACT', 'email': 'polynice.t@chu-toulouse.fr'}], 'overallOfficials': [{'name': 'Guillaume LE COSQUER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}