Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-01-27 @ 1:57 AM
Study NCT ID:
NCT02954705
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2016-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MICRO-RNAs OF NEUTROPHILS IN RENAL ANTINEUTROPHIL CYTOPLASMIS ANTIBODY (ANCA) -ASSOCIATED VASCULITIS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056648', 'term': 'Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis'}], 'ancestors': [{'id': 'D056647', 'term': 'Systemic Vasculitis'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '50 mL of blood and 10 mL of urine by patient'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-21', 'studyFirstSubmitDate': '2016-11-02', 'studyFirstSubmitQcDate': '2016-11-02', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expression profile of miRNAs in patients with AAV in circulating neutrophils, plasma and urine.', 'timeFrame': '6 month after maintenance treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['ANCA-associated Vasculitis']}, 'descriptionModule': {'briefSummary': 'Activation of neutrophils by ANCA ("Anti-Neutrophil Cytoplasm Antibodies") and subsequent microvascular endothelial cell damage is the main feature of ANCA-associated vasculitis (AAV), a severe autoimmune disease that often targets the kidney. There is no specific treatment for AAV to date and 25% of patients with renal damage evolve towards end-stage renal disease, requiring dialysis and kidney transplantation. In addition, there is no reliable biological marker of the disease activity available, which makes the diagnostic, follow-up and treatment of patients difficult. Therefore, the identification of new therapeutic targets and non-invasive biomarkers constitutes a major clinical challenge to improve AAV patients care and to ameliorate their renal outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This will be done in total in 50 patients with ANCA-associated vasculitis (AAV) and 20 control patients. Among the 50 patients with AAV, 30 patients will be newly diagnosed and 20 already followed for AAV', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for patients:\n\n* Adult patients aged over 18 years\n* Patients with Granulomatosis with polyangiitis or microscopic polyangiitis meeting the criteria of Chapel Hill.\n* corticosteroid treatment \\<20 mg / day.\n* Informed consent: oral for participation in research and writing for biological collection.\n\nInclusion Criteria for controls patients:\n\n\\- healthy-topics matched for age, recruited from the Etablissement français du sang or in the Department of Internal Medicine of Nantes University Hospital\n\nNon Inclusion Criteria:\n\n* ANCA-associated vasculitis with Eosinophilic granulomatosis with polyangiitis (AAV-EGPA).\n* Infectious or progressive tumor pathology.\n* Pregnancy, lactation\n* Treatment with cyclophosphamide in the 6 months prior to inclusion.\n* Terminal chronic renal failure, presence of organ allograft.\n* Thrust Patients receiving corticosteroids\\> 20 mg / d in the previous 4 weeks.\n* Inability to give informed about information (subject in emergencies, understanding of the subject of difficulty, ...)\n* Minor subject, under judicial protection, guardianship'}, 'identificationModule': {'nctId': 'NCT02954705', 'acronym': 'MINERVA', 'briefTitle': 'MICRO-RNAs OF NEUTROPHILS IN RENAL ANTINEUTROPHIL CYTOPLASMIS ANTIBODY (ANCA) -ASSOCIATED VASCULITIS', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'MICRO-RNAs OF NEUTROPHILS IN RENAL ANCA-ASSOCIATED VASCULITIS', 'orgStudyIdInfo': {'id': 'RC15_0454'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group AAV', 'description': 'Patients recruited from the Nantes University Hospital. 50 milliliter of blood and 10mL of urine are collected from these patients during levies in clinical visit.', 'interventionNames': ['Other: Non interventional study']}, {'label': 'Group control', 'description': 'People recruited from the "Etablissement français du sang" (French blood establishment ).\n\n10 milliliter of blood are collected from these donors', 'interventionNames': ['Other: Non interventional study']}], 'interventions': [{'name': 'Non interventional study', 'type': 'OTHER', 'description': 'This is a non interventional study because all levies are performed during visit planned for the care of patients.', 'armGroupLabels': ['Group AAV', 'Group control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'Fadi Fakhouri, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}