[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611075":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":20,"studyPopulation":21,"armGroups":22,"interventions":32,"overallOfficials":40,"centralContacts":44,"locations":53,"responsibleParty":70,"collaborators":17,"id":72,"slug":17,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":17,"enrollmentInfo":81,"targetDuration":17,"studyType":84,"phases":17,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":55,"whyStopped":17,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Niguarda Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Molecular profile","Collect and analyse blood and tissue samples from both cases and control in terms of molecular profile","Jul2024-Jul2029",[14],{"measure":15,"description":16,"timeFrame":12},"Molecular targets","Collection and alalysis of blood and tissue samples from both cases and control in term of molecular profile.\n\nTo identify the percentage and types of actionable molecular targets that could be amenable of potential targeted treatment according to the ESMO Scale for Clinical Actionability of molecular Targets (ESCAT). To test the concordance of liquid biopsy NGS ctDNA with tissue-based NGS analyses in a subset of patients where both tissue and blood samples are available.",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":6,"maskingInfo":17},"CASE_CONTROL","This is a nonprofit, observational, prospective and retrospective, multicenter study. The primary objectives of this study are: (i) to assess the efficacy of liquid biopsy using ctDNA NGS in identifying tumor-specific somatic alterations in patients with cardiac malignancies, particularly primary cardiac sarcomas (PCS), and to differentiate these from benign cardiac lesions. Liquid biopsy, consisting of a venous blood samplecollected during routine venipuncture, will assess the nature of circulating DNA by a commercial NGS assay (i.e., Guardant Infinity, Guardant Health) and\u002For academic assays. When solid biopsy is available since previouslyperformed as per clinical practice, tumor DNA will be assessed by a commercial issue NGS assay (i.e., FoundationOne, Foundation Medicine) and\u002For academic assays","control:benign cardiac lesions; case:primary cardiac sarcomas young and adult patients with a diagnosis of a cardiac mass",[23,28],{"label":24,"type":17,"description":25,"interventionNames":26},"benign cardiac lesions","patients diagnosed with benign cardiac lesions",[27],"Genetic: NGS-guided regimen: Regimen A",{"label":29,"type":17,"description":30,"interventionNames":31},"primary cardiac sarcomas","patients diagnosed with primary cardiac sarcomas (PCS)",[27],[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"GENETIC","NGS-guided regimen: Regimen A","Liquid biopsy, consisting of a venous blood sample, will be collected during routine venipuncture",[24,29],[39],"collection of blood for NGS and archival tissue sample, where available",[41],{"name":42,"affiliation":5,"role":43},"Katia Bencardino, MD","PRINCIPAL_INVESTIGATOR",[45,50],{"name":42,"role":46,"phone":47,"phoneExt":48,"email":49},"CONTACT","+39026444","3695","katia.bencardino@ospedaleniguarda.it",{"name":51,"role":46,"phone":47,"phoneExt":48,"email":52},"Giorgio Patelli, MD","giorgio.patelli@ospedaleniguarda.it",[54],{"facility":5,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"RECRUITING","Milan","Italia","20262","Italy","IT",{"type":62,"coordinates":63},"Point",[64,65],12.59836,42.78235,{"lat":65,"lon":64},[68,69],{"name":42,"role":46,"phone":47,"phoneExt":48,"email":49},{"name":51,"role":46,"phone":47,"phoneExt":48,"email":52},{"type":71,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100611075",false,"NCT07235865","Non-Invasive Diagnosis and Monitoring of Cardiac Masses by Liquid Biopsy","Non-Invasive Diagnosis and Monitoring of Cardiac Masses by Liquid Biopsy: The CarMA Study","CarMA","Inclusion Criteria\n\n1. Age ≥12 years old\n2. Suspected or confirmed diagnosis of a cardiac mass of any nature as assessed by standard clinical, radiological and\u002For pathological procedures.\n\nExclusion Criteria\n\n1\\. Inability of the pa ent to fully understand and sign the informed consent.","ALL","12 Years",{"count":82,"type":83},26,"ESTIMATED","OBSERVATIONAL","This is a nonprofit, observational, prospective and retrospective,multicenter study in a population of young and adult patients ≥12 years with a diagnosis of a cardiac mass. The study will include both patients with masses of unknown pathological diagnosis and patients with a known histology of benign or malignant tumors. We predict a case-control allocation ratio of 1:1 between cardiac malignant tumors and benign lesions. Peripheral blood will be collected at participating centers during routine venipuncture,processed and then shipped for liquid biopsy ctDNA NGS analyses. If available, in malignant cases, matched tumor tissue samples collected as per clinical practice solid biopsies or surgery will be used for analyses. Longitudinal tracking through serial blood draws could be performed in selected cases of patients with cardiac malignancies who receive cancer treatment",[87],"Cardiac Masses",[89],"Early-Onset Colorectal Cancer","2026-04-13",{"date":92,"type":93},"2026-04-15","ACTUAL",{"date":95,"type":93},"2024-07-25",{"date":97,"type":83},"2026-12-25",{"name":5,"class":6},1]