[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591511":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":30,"responsibleParty":97,"collaborators":99,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":104,"sex":110,"minAge":111,"maxAge":10,"enrollmentInfo":112,"targetDuration":10,"studyType":115,"phases":10,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Santa Chiara Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Metastatic Castration Resistant Prostate Cancer (mCRPC) patients",null,"This group includes mCRPC patients treated with serial lines of treatment.\n\nFor each line of treatment, blood samples are collected:\n\n1. Before starting the treatment;\n2. After 12 weeks;\n3. At the end of the treatment\u002Fprogression.",[13],"Diagnostic Test: Analysis of cell free DNA, and extracellular vesicles (EVs) and EV-associated molecular components (including RNA, DNA, proteins)",{"label":15,"type":10,"description":16,"interventionNames":17},"Metastatic Hormon Sensitive Prostate Cancer (mHSPC) patients","This group includes mHSPC patients treated with hormone therapy.\n\nIn the hormone sensitive setting, blood samples are collected:\n\n1. Before starting the treatment;\n2. After 12 weeks;\n3. Every six months until progression to the castration resistant status.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DIAGNOSTIC_TEST","Analysis of cell free DNA, and extracellular vesicles (EVs) and EV-associated molecular components (including RNA, DNA, proteins)","Plasma and buffy coat samples are shipped from the recruiting clinical sites to the lab of Professor Francesca Demichelis at the University of Trento (UniTN).\n\nAt UniTN, samples are stored in dedicated freezers with restricted access and subsequently used as follows:\n\n* the plasma is used for the isolation of cell free DNA and extracellular vesicles (EVs);\n* the buffy coat is used for the extraction of genomic DNA.\n\nNucleic acids sequencing library preparations and all downstream omics analyses are performed by Prof. Demichelis team.",[9,15],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Orazio Caffo","CONTACT","+39 0461902121","orazio.caffo@apss.tn.it",[31,52,68,84],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Istituto Romagnolo per lo Studio dei Tumori","RECRUITING","Meldola","Forlì-Cesena","47014","Italy","IT",{"type":40,"coordinates":41},"Point",[42,43],12.0626,44.12775,{"lat":43,"lon":42},[46,50],{"name":47,"role":27,"phone":48,"phoneExt":10,"email":49},"Ugo De Giorgi, MD, PhD","00390543739123","ugo.degiorgi@irst.emr.it",{"name":47,"role":51,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"facility":53,"status":33,"city":54,"state":55,"zip":56,"country":37,"countryCode":38,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Azienda Ospedaliera San Luigi","Orbassano","Torino","10043",{"type":40,"coordinates":58},[59,60],7.53813,45.00547,{"lat":60,"lon":59},[63,67],{"name":64,"role":27,"phone":65,"phoneExt":10,"email":66},"Consuelo Buttigliero, MD, PhD","+390116705492","consuelo.buttigliero@unito.it",{"name":64,"role":51,"phone":10,"phoneExt":10,"email":10},{"facility":69,"status":33,"city":70,"state":10,"zip":71,"country":37,"countryCode":38,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Istituto Oncologico Veneto","Padova","35128",{"type":40,"coordinates":73},[74,75],11.14261,44.38225,{"lat":75,"lon":74},[78,82],{"name":79,"role":27,"phone":80,"phoneExt":10,"email":81},"Umberto Basso, MD","+39-049-8215953","umberto.basso@iov.veneto.it",{"name":83,"role":51,"phone":10,"phoneExt":10,"email":10},"Basso Umberto",{"facility":5,"status":33,"city":85,"state":10,"zip":86,"country":37,"countryCode":38,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Trento","38122",{"type":40,"coordinates":88},[89,90],11.12108,46.06787,{"lat":90,"lon":89},[93,96],{"name":94,"role":27,"phone":95,"phoneExt":10,"email":29},"Orazio Caffo, MD","+39 046190212",{"name":26,"role":51,"phone":10,"phoneExt":10,"email":10},{"type":51,"investigatorFullName":26,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Director, Medical Oncology Unit",[100],{"name":101,"class":6},"Università degli Studi di Trento","100591511","prostate-cancer-plasma-integrative-multi-modal-evaluation-100591511",false,"NCT06981377","PRostate Cancer Plasma Integrative Multi-modal Evaluation","Development of the PRIME Test for the Identification of Prostate Cancer Patients' Biomarkers Through Non-invasive Liquid Biopsies","PRIME","Inclusion Criteria:\n\n* Diagnosis of prostate cancer\n* Eligible for prostate cancer pharmacological treatment\n* Given consent to study participation\n\nExclusion Criteria:\n\n\\- Histological diagnosis other than prostate cancer","MALE","18 Years",{"count":113,"type":114},800,"ESTIMATED","OBSERVATIONAL","The study aims to develop PRIME (PRostate cancer plasma Integrative Multi-modal Evaluation) liquid biopsy test and to implement its use to query prospectively collected samples in advanced prostate cancer (PCa) clinical trials and\u002For clinical settings. In order to maximise the utility of liquid biopsies for advanced PCa, PRIME is focused on the development of novel computational and sequencing approaches that integrate multiple information from plasma circulating elements: i) cell free DNA (cfDNA) gene mutation data with accurate quantitation of cfDNA structural genomic changes, ii) cfDNA genomic profiling with cfDNA methylation status, and iii) the information provided by extracellular vesicles (EVs) and EV-associated cargo (including DNA, RNA and proteins).",[118],"Metastatic Prostate Cancer",[120,121,122,123],"Liquid biopsy","Cell free DNA (cfDNA)","Extracellular Vesicles (EVs)","Biomarkers","2025-05-13",{"date":126,"type":127},"2025-05-20","ACTUAL",{"date":129,"type":127},"2019-05-07",{"date":131,"type":114},"2027-01-31",{"name":5,"class":6},4]