Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-02-25 @ 6:33 PM
Study NCT ID:
NCT06894602
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-27
First Post:
2025-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Ultrasonographic Temporal Artery Lesions and Relapse in Patients With Giant Cell Arteritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013700', 'term': 'Giant Cell Arteritis'}], 'ancestors': [{'id': 'D020293', 'term': 'Vasculitis, Central Nervous System'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001167', 'term': 'Arteritis'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2025-03-19', 'studyFirstSubmitQcDate': '2025-03-19', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse according to EULAR 2018 criteria', 'timeFrame': 'At 12 months', 'description': 'Relapse is defined with European League Against Rheumatism recommendations according to major or minor relapse criteria.'}], 'secondaryOutcomes': [{'measure': 'Relapse according to EULAR 2018 criteria', 'timeFrame': 'At 6 month; at 12 month', 'description': 'Relapse is defined with European League Against Rheumatism recommendations according to major or minor relapse criteria.'}, {'measure': 'Clinical parameter : Age', 'timeFrame': 'At inclusion', 'description': 'One Clinical parameter is defined with the dichotomised variable : age \\> 50 years (YES) and age \\<=50 years (NO)'}, {'measure': 'Other prognostic marker : C-Reactive Protein', 'timeFrame': 'At inclusion, At 6 month, At 12 month', 'description': 'Pronostic markers are defined with C-Reactive Protein (in mg/L)'}, {'measure': 'OMERACT Giant Cells arteritis Ultrasonography Score (OGUS)', 'timeFrame': 'At 6 month, at 12 month', 'description': 'It is a score for ultrasound monitoring of temporal arteries by measuring the intima media complex of 8 vascular sites (common temporal trunk, frontal and parietal branches, axillary arteries). If OGUS score is \\>= 1, the criteria is YES, if OGUS score \\< 1, the criteria is NO'}, {'measure': 'C-Reactive Protein', 'timeFrame': 'At 6 month, at 12 month', 'description': 'It is a biological marker expressed in mg/L. If CRP \\>=10 mg/L, the criteria is YES. If CRF \\< 10 mg/L, the criteria is NO'}, {'measure': 'Erythrocyte Sedimentation Rate (ESR)', 'timeFrame': 'At 6 month, at 12 month', 'description': 'It is a blood test that can show the inflammation in the body, in mm/hour. If ESR \\>= 15 mm/h, the criteria is YES. If ESR \\< 15 mm/h, the criteria is NO.'}, {'measure': 'Clinical parameter : loss of vision', 'timeFrame': 'At inclusion', 'description': 'One Clinical parameter is defined with the sudden loss of vision (YES/NO)'}, {'measure': 'Clinical parameter : claudication of the jaw or tongue', 'timeFrame': 'At inclusion', 'description': 'One Clinical parameter is defined with the claudication of the jaw or tongue (YES/NO)'}, {'measure': 'Clinical parameter : temporal headaches', 'timeFrame': 'At inclusion', 'description': 'One Clinical parameter is defined with the temporal headaches (YES/NO)'}, {'measure': 'Clinical parameter : scalp paresthesia', 'timeFrame': 'At inclusion', 'description': 'One Clinical parameter is defined with the scalp paresthesia (YES/NO)'}, {'measure': 'Clinical parameter : abnormal palpation of the temporal arteries', 'timeFrame': 'At inclusion', 'description': 'One Clinical parameter is defined with the abnormal palpation of the temporal arteries (YES/NO)'}, {'measure': 'Clinical parameter : morning stiffness of shoulders and/or neck', 'timeFrame': 'At inclusion', 'description': 'One Clinical parameter is defined with morning stiffness of shoulders and/or neck (YES/NO)'}, {'measure': 'Biological parameter : temporal artery biopsy', 'timeFrame': 'At inclusion', 'description': 'One biological parameter is defined with positive temporal artery biopsy (YES/NO)'}, {'measure': 'Biological parameter : halo sign on ultrasound', 'timeFrame': 'At inclusion', 'description': 'One biological parameter is defined with halo sign on ultrasound (Present/Absent)'}, {'measure': 'Biological parameter : bilateral axillary involvement', 'timeFrame': 'At inclusion', 'description': 'One biological parameter is defined with bilateral axillary involvement (occlusion or stenosis visualized on ultrasound or CT angio or PET scan or MRI)(Present/Absent)'}, {'measure': 'Biological parameter : aortitis', 'timeFrame': 'At inclusion', 'description': 'One biological parameter is defined with aortitis on PET scans of the thoracic or abdominal descending aorta (Present/Absent)'}, {'measure': 'Biological parameter : Sedimentation rate', 'timeFrame': 'At inclusion', 'description': 'One biological parameter is defined with Sedimentation rate \\>= 50 mm/hour (YES/NO)'}, {'measure': 'Biological parameter : C-Reactive Protein', 'timeFrame': 'At inclusion', 'description': 'One biological parameter is defined with C-Reactive Protein \\>= 10 mg/L at the first hour (YES/NO)'}, {'measure': 'Other prognostic marker : hemoglobin', 'timeFrame': 'At inclusion, At 6 month, At 12 month', 'description': 'Pronostic markers are defined with hemoglobin (in g/dL)'}, {'measure': 'Other prognostic marker : leukocytes', 'timeFrame': 'At inclusion, At 6 month, At 12 month', 'description': 'Pronostic markers are defined with leukocytes (in giga/L)'}, {'measure': 'Other prognostic markers : platelets', 'timeFrame': 'At inclusion, At 6 month, At 12 month', 'description': 'Pronostic markers are defined with platelets (in giga/L)'}, {'measure': 'Other prognostic marker : Sedimentation rate', 'timeFrame': 'At inclusion, At 6 month, At 12 month', 'description': 'Pronostic markers are defined with Sedimentation rate (in mm/hour)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['giant cell arteritis', 'Ultrasound', 'follow up', 'monitoring', 'OGUS score'], 'conditions': ['Giant Cell Arteritis']}, 'descriptionModule': {'briefSummary': 'Ultrasound evaluation of the temporal and axillary arteries is currently well recognized in the field of giant cell arteritis (GCA), a disease primarily affecting medium- and large-caliber vessels. Structural ultrasound abnormalities are now well described in this pathology, but their association with relapse and clinical concordance is unknown. There is currently a follow-up score (the OGUS score) for medium- and large-caliber arteries that could also predict the clinical course of the disease.', 'detailedDescription': 'Prospective bicentric longitudinal study evaluating the association between ultrasound lesions and clinico-biological relapse in patients with giant cell arteritis.\n\nThis is a non-interventional study with patients routinely followed for their pathology and classically benefiting from temporal artery ultrasound as part of their disease. Recruitment will be facilitated by the fact that these will be "general population" patients with suspected giant cell arteritis.\n\nThe center will enroll 100 patients. The study will take place over 3 visits, including a clinical, biological and ultrasound examination. Ultrasound will not be blinded to the clinic, so we will only need one examiner in the center.\n\nThis is a study in routine care, with no additional costs and no expected constraints. The ultrasound examination will be performed as part of their routine follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with giant cell arteritis at disease diagnosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major patient\n* Patients meeting ACR 2022 criteria for giant cell arteritis.\n* No opposition expressed\n\nExclusion Criteria:\n\n* Patients unable to understand the protocol, under guardianship or curatorship.\n* Patients not affiliated to the French Social Security system.'}, 'identificationModule': {'nctId': 'NCT06894602', 'acronym': 'ALERT', 'briefTitle': 'Association of Ultrasonographic Temporal Artery Lesions and Relapse in Patients With Giant Cell Arteritis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Association of Ultrasonographic Temporal Artery Lesions and Relapse in Patients With Giant Cell Arteritis', 'orgStudyIdInfo': {'id': '29BRC24.0371 - ALERT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with giant cell arteritis at diagnosis', 'description': 'patients routinely monitored for their disease, and who typically benefit from temporal artery ultrasound as part of their disease. Recruitment will be facilitated by the fact that these are "general population" patients with suspected giant cell arteritis.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '29200', 'city': 'Brest', 'country': 'France', 'contacts': [{'name': 'Sandrine Pr JOUSSE-JOULIN', 'role': 'CONTACT', 'email': 'sandrine.jousse-joulin@chu-brest.fr', 'phone': '0298347267', 'phoneExt': '+33'}, {'name': 'Sandrine Pr JOUSSE-JOULIN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chu Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '29107', 'city': 'Quimper', 'country': 'France', 'contacts': [{'name': 'Guillaume Dr DERRIEN', 'role': 'CONTACT', 'email': 'guillaume.derrien@ch-cornouaille.fr', 'phone': '298526803', 'phoneExt': '+33'}, {'name': 'Guillaume Dr DERRIEN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ch Quimper', 'geoPoint': {'lat': 47.99597, 'lon': -4.09795}}], 'centralContacts': [{'name': 'Sandrine Pr JOUSSE-JOULIN', 'role': 'CONTACT', 'email': 'sandrine.jousse-joulin@chu-brest.fr', 'phone': '298347267', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available beginning three years and ending fifteen years following the final study report completion', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}