Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT03767712
Status:
COMPLETED
Last Update Posted:
2020-04-07
First Post:
2018-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trauma as a Trigger for Autoimmunity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum samples of each subject in a form of biobank (TATA-Biobank) in order to allow future analyses (e.g. emerging biomarkers in relation to trauma).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-06', 'studyFirstSubmitDate': '2018-12-04', 'studyFirstSubmitQcDate': '2018-12-04', 'lastUpdatePostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in ANA', 'timeFrame': 'Preoperative (1-2 days preoperative) and 12 weeks postoperative', 'description': 'Fluorescence Index (FI) for ANA measurement (automated digital fluorescence microscopy = indirect immunofluorescence on a Hep-2 cell line). In order to overcome the problem of subjective semiquantitative evaluation, the novel method of automated digital fluorescence microscopy will be used (NOVA View, INOVA Diagnostics'}], 'secondaryOutcomes': [{'measure': 'Change in ANA', 'timeFrame': '6 weeks postoperative and 12 weeks postoperative and 12 months postoperative', 'description': 'Fluorescence Index (FI) for ANA measurement (automated digital fluorescence microscopy)'}, {'measure': 'Change in Antibody level against double stranded deoxyribonucleic acid (Anti-dsDNA)', 'timeFrame': 'Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative', 'description': 'serum level of Anti-dsDNA (U/ml)'}, {'measure': 'Change in Antibody level against Anti-Cardiolipin', 'timeFrame': 'Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative', 'description': 'serum level of Anti-Cardiolipin (U/ml)'}, {'measure': 'Change in Antibody level against complement component C1q (Anti-C1q)', 'timeFrame': 'Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative', 'description': 'serum level of C1q (U/ml)'}, {'measure': "Change in Antibody level against Sjögren's-syndrome-related antigen A (Anti-SSA/Ro)", 'timeFrame': 'Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative', 'description': 'serum level of Anti-SSA/Ro (U/ml)'}, {'measure': 'Change in proportion of immune cells (Plasmablasts, regulatory T cell (T-regs), total Cluster of Differentiation (CD)4+, CD8+, CD19+, Natural killer (NK) cells', 'timeFrame': 'Preoperative (1-2 days preoperative) and 3-4 days postoperative and 6 weeks postoperative and 12 weeks postoperative', 'description': 'Change in proportion of immune cells (Plasmablasts, regulatory T cell (T-regs), total Cluster of Differentiation (CD)4+, CD8+, CD19+, Natural killer (NK) cells (cells/ml)'}, {'measure': 'Change in serum levels of cytokines (Interleukin (IL)-6 , IL-10, IL-18, Tumor necrosis factor (TNF)-a , Tumor necrosis factor receptor two (TNF-RII)', 'timeFrame': 'Preoperative (1-2 days preoperative) and 3-4 days postoperative and 6 weeks postoperative and 12 weeks postoperative', 'description': 'Change in serum levels of cytokines (Interleukin (IL)-6 , IL-10, IL-18, Tumor necrosis factor (TNF)-a , Tumor necrosis factor receptor two (TNF-RII)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['trauma', 'immunological reaction to trauma', 'pertrochanteric femoral fracture', 'antinuclear antibodies', 'activation of innate immunity', 'adaptive immunity'], 'conditions': ['Autoimmunity']}, 'descriptionModule': {'briefSummary': 'To analyse the immunological reaction to Trauma (pertrochanteric femoral fracture with consequent osteosynthesis) in the first weeks up to one year postoperatively with focus on the development of autoimmunity.', 'detailedDescription': 'This project represents a unique study of the influence of trauma on the immune system. It addresses the question whether an excess of apoptotic/necrotic cells can induce an at least transient autoimmune phenomena in humans. If the hypothesis of a transient induction of autoimmunity by trauma proves to be correct, this study will provide a novel insight into the pathogenesis of autoimmune diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute pertrochanteric fracture in whom an operation (gamma-nail osteosynthesis) is planned at the University Hospital Basel.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pertrochanteric femoral fracture (≤7 days)\n* planned gamma nail osteosynthesis\n* ability to give written informed consent\n\nExclusion Criteria:\n\n* Severe hepatic and renal failure\n* current active oncological disease\n* current immunosuppressive or biological therapy\n* known systemic autoimmune disease\n* foreseeable lack of complete follow-up (e.g. due to generally poor health)\n* cognitive impairment (delirium, dementia, alteration of consciousness)\n* insufficient knowledge of project language\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT03767712', 'acronym': 'TATA', 'briefTitle': 'Trauma as a Trigger for Autoimmunity', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Trauma as a Trigger for Autoimmunity - a Single Centre Observational Cohort Study', 'orgStudyIdInfo': {'id': '2016-00895, me16Potlukova'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Comparison of the levels of antinuclear antibodies (ANA) by indirect immunofluorescence on a Hep-2 cell line.', 'type': 'DIAGNOSTIC_TEST', 'description': 'To analyse whether patients with pertrochanteric femoral fracture with consecutive gamma-nailing develop any laboratory signs of transient autoimmunity (comparison of the levels of ANA; in order to overcome the problem of subjective semiquantitative evaluation, the novel method of automated digital fluorescence microscopy will be used)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Eliska Potlukova, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik für Innere Medizin, Universitätsspital Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}