[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534841":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":35,"centralContacts":39,"locations":10,"responsibleParty":44,"collaborators":10,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":10,"enrollmentInfo":57,"targetDuration":10,"studyType":60,"phases":10,"briefSummary":61,"conditions":62,"keywords":68,"overallStatus":74,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":10},{"fullName":5,"class":6},"ASST Fatebenefratelli Sacco","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"GCA patients",null,"Patients who are going to be diagnosed with GCA and for which a fast track is available for a rapid diagnostic work-up including pre-treatment temporal artery biopsy. The main biopsy specimen will be sent for histopathology for clinical diagnosis or final validation, while the remaining specimen (at least 5 mm in length) will be digested to use for research purposes. In the fast-track, patients should rapidly receive a multi-dimensional diagnostic assessment including ultrasonography of the temporal and axillary arteries. Screening for large vessels involvement should be performed according to the local practice by a combination of ultrasonography, Position Emission Tomography (PET) and Magnetic Resonance (MR). Ideally, this assessment should be performed within five days from clinical evaluation.",[13,14,15],"Diagnostic Test: Temporal arterial biopsy","Diagnostic Test: Whole exome sequencing","Diagnostic Test: Single cell transcriptomics",{"label":17,"type":10,"description":18,"interventionNames":10},"Healthy subjects","Healthy controls matched with GCA patients for age, sex, smoking status, previous cardiovascular events, BMI, history of cancer and cytotoxic chemo\u002Fradiotherapy.",[20,25,31],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DIAGNOSTIC_TEST","Temporal arterial biopsy","Collection of 30 ml of peripheral blood in ethylenediaminetetraacetic acid (EDTA) tubes performed at baseline, 6 months, 12 months and in case of flare before month 12. In addition, the temporal artery specimen (at least 5 mm in length) exceeding that used for clinical activity (at least 10 mm in length in accordance with current clinical recommendations) will be digested to use for research purposes (about protocols for collecting, processing, storing and sending biopsy, refer to Standard Operating Procedures, SOP).",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Whole exome sequencing","Patients with CHIP will be identified and characterized by using whole exome sequencing from the peripheral blood samples. M-CHIP will be further characterized by:\n\ni) clone dimension as defined by Variant Allele Fraction (VAF); ii) mutations in specific genes such as DNMT3A, Tet methylcytosine dioxygenase 2 (TET2), Additional Sex combs (ASXL1), or Janus kinase 2 (JAK2); iii) multiple mutations.\n\nL-CHIP will be further characterized by:\n\ni) clone dimension as defined by the VAF; ii) mutations in specific genes such as Dual Specificity Phosphatase 22 (DUSP22), FAT atypical cadherin 1 (FAT1), (Histone-lysine N-methyltransferase 2D (KMT2D); iii) multiple mutations; iv) co-occurrence of mutations heralding M- and L-CHIP.",[9],[30],"Genetic analysis for CHIP",{"type":21,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"Single cell transcriptomics","The investigators will identify actively inflamed arterial biopsies from three treatment-naïve patients without CHIP, and three treatment-naïve patients with CHIP driven by the most relevant gene mutation. Arterial wall Cluster of Differentiation (CD) 45+ leukocytes will be isolated after digestion of arterial tissue and characterized by single cell transcriptomics, with a specific focus on wall infiltrating T cells and macrophages and their subsets (eg: Vascular dendritic cells, Th1, Th2, Th17, Treg, M1- and M2-like,…). Frequencies of these subsets and their genetic expression will be compared between wall-infiltrating leukocytes from GCA patients with or without CH, focusing on histological events supposed to be pathogenic in GCA, or known to be dysfunctional in CHIP.",[9],[36],{"name":37,"affiliation":5,"role":38},"Enrico Tombetti, Dr.","PRINCIPAL_INVESTIGATOR",[40],{"name":37,"role":41,"phone":42,"phoneExt":10,"email":43},"CONTACT","+393289098793","enrico.tombetti@asst-fbf-sacco.it",{"type":38,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Enrico Tombetti","Principal Investigator","100534841","clonal-hematopoiesis-in-giant-cell-arteritis-100534841",false,"NCT06244069","Clonal Hematopoiesis in Giant Cell Arteritis","CH-GCA","Inclusion Criteria:\n\n* Patients with suspected active GCA entering into a fast-track work-up and healthy matched controls.\n* Capability of providing valid consent to study enrollment.\n* Possibility of performing temporal artery biopsy within three hours from enrollment.\n\nExclusion Criteria:\n\n* Active concurrent viral, fungal or bacterial infections (including active\u002Flatent tuberculosis treated for less than 4 weeks, HIV and Hepatitis B\u002FC virus (HBV\u002FHCV) infections.\n* Concurrent systemic inflammation not attributable to GCA (inflammatory diseases in treatment-free remission are accepted).\n* Use of other immunosuppressive agents in the last 3 months.\n* Use of systemic steroids (any dose in the last week, \\> 15 mg\u002Fdie of prednisone equivalent in the last month).\n* Solid or hematologic malignancies (active or with less than 6 months free of disease or antiblastic chemotherapy (hormone therapy is allowed).\n* Previous solid or hematopoietic stem cell transplantation (corneal transplants are allowed).\n* Any systemic immunosuppressive or steroidal therapy.\n* Chronic renal failure with Glomerular Filtration Rate (GFR) \\\u003C 45 ml\u002Fmin \\*1.73 m2.\n* Moderate-severe liver failure (Child-Pugh B or C), hepatitis in stages of activity.\n* Diabetes mellitus.\n* Heart failure with New York Heart Association score (NYHA) \\>=2.\n* Severe hypoproteinemia\u002Fmalnutrition.\n* Chronic respiratory failure requiring O2 therapy or ventilation therapy at home.\n* Any other condition judged by the local investigator as a contra-indication to eligibility.",true,"ALL","18 Years",{"count":58,"type":59},326,"ESTIMATED","OBSERVATIONAL","The goal of this clinical trial is to verify whether CHIP is correlated with the clinical, instrumental, and histological characteristics of GCA, and to characterize the pathogenetic effects of clonal hemopoiesis on vasculitis. The main objective of this study is to verify if clonal hematopoiesis of indeterminate potential (CHIP) affects GCA manifestations, course\u002Fresponse to therapies, and pathogenesis.\n\nPatients who are going to be diagnosed with GCA and for which a fast track is available for a rapid diagnostic work-up including pre-treatment temporal artery biopsy. Patients with CHIP will be identified and characterized by using whole exome sequencing from the peripheral blood samples. The presence and characteristics of CHIP will be correlated with baseline clinical, instrumental, and histologic GCA features.",[63,64,65,66,67],"Giant Cell Arteritis","Temporal Arteritis","Clonal Hematopoiesis of Indeterminate Potential","Horton Disease","Systemic Vasculitis Primary",[69,70,65,32,71,72,73],"Temporal artery biopsy","Giant cell arteritis","Large vessels vasculitis","Horton disease","Whole Exome Sequencing","NOT_YET_RECRUITING","2024-02-02",{"date":77,"type":78},"2024-02-06","ACTUAL",{"date":80,"type":59},"2024-03",{"date":82,"type":59},"2031-03",{"name":5,"class":6}]