Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT07256418
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-01
First Post:
2025-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transcriptomic Study of Cutaneous Fibroblasts in Scleroderma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045743', 'term': 'Scleroderma, Diffuse'}], 'ancestors': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2025-11-20', 'studyFirstSubmitQcDate': '2025-11-20', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'genes involved in the various cell activation and signalling pathways', 'timeFrame': 'through study completion, an average of 12 months', 'description': 'number and type of genes involved in different cell activation and signalling pathways, including senescence, which will be differentially expressed in fibroblasts from the skin of control participants and those from the skin of subjects with SSc.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Scleroderma']}, 'descriptionModule': {'briefSummary': 'Scleroderma is a complex connective tissue disease involving three interconnected pathophysiological axes: vascular hyperactivity and remodelling, immune system dysfunction and over-activation of fibroblasts at the origin of the fibrosis process in the skin and organs. Given that this pathology occurs preferentially in mature subjects, it is possible to suggest a potential inductive role for senescent fibroblasts, which would be responsible for activating and/or maintaining the immune response and systemic inflammation. Our hypothesis is that fibroblasts play a predominant role in the genesis and maintenance of this pathology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible participants (patients and control participants) will be identified during their usual follow-up consultation.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFOR PATIENTS WITH SCLERODERMA :\n\n* Person who has given written consent\n* Person with systemic scleroderma\n\nFOR CONTROL PARTICIPANTS :\n\n* Person who has given written consent\n* Person undergoing plastic, cosmetic and reconstructive surgery\n\nExclusion Criteria:\n\nFOR PATIENTS WITH SCLERODERMA :\n\n* Person not affiliated to or not benefiting from a social security scheme\n* Person subject to a legal protection measure (curatorship, guardianship)\n* Person subject to a legal protection measure\n* An adult who is incapable or unable to give consent\n* Minors\n\nFOR CONTROLLED PARTICIPANTS :\n\n* Person suffering from a chronic disease or under chronic treatment for autoimmune, inflammatory or dermatological diseases\n* Person not affiliated to or not benefiting from a social security scheme\n* Person under legal protection (curatorship, guardianship)\n* Person subject to a legal protection measure\n* An adult who is incapable or unable to give consent\n* Minors'}, 'identificationModule': {'nctId': 'NCT07256418', 'acronym': 'TRANSCLERO', 'briefTitle': 'Transcriptomic Study of Cutaneous Fibroblasts in Scleroderma', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Transcriptomic Study of Cutaneous Fibroblasts in Scleroderma', 'orgStudyIdInfo': {'id': 'BONNOTTE 2025-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'scleroderma', 'description': 'People with systemic scleroderma', 'interventionNames': ['Procedure: Skin samples', 'Other: Analysis of fibroblasts']}, {'label': 'Control', 'description': 'People undergoing plastic, cosmetic and reconstructive surgery', 'interventionNames': ['Procedure: Skin samples', 'Other: Analysis of fibroblasts']}], 'interventions': [{'name': 'Skin samples', 'type': 'PROCEDURE', 'description': '* Scleroderma group: skin biopsy for scleroderma patients\n* Control group: recovery of resected tissue from patients undergoing plastic, reconstructive and aesthetic surgery.', 'armGroupLabels': ['Control', 'scleroderma']}, {'name': 'Analysis of fibroblasts', 'type': 'OTHER', 'description': 'Analysis of samples by RNA sequencing', 'armGroupLabels': ['Control', 'scleroderma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'country': 'France', 'contacts': [{'name': 'Bernard BONOTTE', 'role': 'CONTACT', 'email': 'Bernard.bonnotte@chu-dijon.fr', 'phone': '03.80.29.34.32', 'phoneExt': '+33'}], 'facility': 'CHU Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}], 'centralContacts': [{'name': 'Bernard BONNOTTE', 'role': 'CONTACT', 'email': 'Bernard.bonnotte@chu-dijon.fr', 'phone': '03.80.29.34.32', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}