Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-31 @ 5:36 PM
Study NCT ID:
NCT07015060
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-11
First Post:
2025-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pathogenic Mechanisms Involved in the Initiation and Progression of Systemic Sclerosis
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2031-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2025-05-22', 'studyFirstSubmitQcDate': '2025-06-02', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identify rare variants in candidate genes and pathways in SSC patients (blood and skin biopsy)', 'timeFrame': 'Through the entire study, approximately during 5 years', 'description': 'Genetic analyses in affected skin from patients (Next Generation sequencing, (single cell) RNASeq, real time qPCR)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Scleroderma (Limited and Diffuse)']}, 'descriptionModule': {'briefSummary': 'Identify rare variants in candidate genes and pathways identified in familial SSc, in patients with sporadic SSc.\n\nPerform (spatial) transcriptomic and proteomic analyses of affected skin from patients with and without cutaneous fibrosis, for the patterns and levels of expression/activation of candidate genes and pathways.\n\nTest for dysregulation of expression/activation of candidate genes and pathways in live cells isolated from the blood and skin biopsy of patients, and for the impact of these dysregulations on cell appearance, behavior and function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with one of the following:\n\n * Limited SSc\n * Limited cutaneous SSc\n * Diffuse cutaneous SSc\n* Patients followed regularly in consultations at CUSL.\n* Patients between ages 18-80.\n\nExclusion Criteria:\n\n* Other (co-occurring) autoimmune/autoinflammatory disease\n* Pregnancy\n* Participants with temporary or definitive disabilities to give consent\n* Participants unable to sign or read the inform consent form'}, 'identificationModule': {'nctId': 'NCT07015060', 'briefTitle': 'Pathogenic Mechanisms Involved in the Initiation and Progression of Systemic Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Université Catholique de Louvain'}, 'officialTitle': 'Pathogenic Mechanisms Involved in the Initiation and Progression of Systemic Sclerosis', 'orgStudyIdInfo': {'id': 'PathSSC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PathSSc', 'interventionNames': ['Procedure: cutaneous biospy']}], 'interventions': [{'name': 'cutaneous biospy', 'type': 'PROCEDURE', 'description': 'cutaneous biospy', 'armGroupLabels': ['PathSSc']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Farah Tamirou, Pr', 'role': 'CONTACT', 'email': 'farah.tamirou@saintluc.uclouvain.be', 'phone': '+32 2 674 53 87'}], 'overallOfficials': [{'name': 'Nisha Limaye, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Université Catholique de Louvain'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}