[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580355":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":43,"studyPopulation":44,"armGroups":45,"interventions":40,"overallOfficials":40,"centralContacts":52,"locations":62,"responsibleParty":363,"collaborators":40,"id":365,"slug":366,"hasResults":367,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":371,"eligibilityCriteria":372,"healthyVolunteers":367,"sex":373,"minAge":374,"maxAge":40,"enrollmentInfo":375,"targetDuration":40,"studyType":378,"phases":40,"briefSummary":379,"conditions":380,"keywords":382,"overallStatus":65,"whyStopped":40,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":393},{"fullName":5,"class":6},"Consorzio Oncotech","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":40},[9,13,15,18,20,22,24,26],{"measure":10,"description":11,"timeFrame":12},"Evaluate the clinical outcomes","The clinical outcomes that will be measured in both study cohorts are:\n\nprogression-free survival (PSF) as the time from treatment's start to disease progression or death for any cause","Until 3 years from enrollment",{"measure":10,"description":14,"timeFrame":12},"The clinical outcomes that will be measured in both study cohorts are:\n\noverall survival (OS) as the time from treatment's start to death for any cause",{"measure":16,"description":17,"timeFrame":12},"Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort","Toxicity evaluated according to CTCAE vers 5.0",{"measure":16,"description":19,"timeFrame":12},"Percentage of patients with dose reductions",{"measure":16,"description":21,"timeFrame":12},"Percentage of patients with dose interruptions due to toxicity",{"measure":16,"description":23,"timeFrame":12},"Percentage of patients with treatment discontinuations due to toxicity",{"measure":16,"description":25,"timeFrame":12},"Toxicity according to initial dose of targeted agents",{"measure":16,"description":27,"timeFrame":12},"Incidence of myelodysplastic syndrome and acute myeloid leukaemia in patients receiving PARPi",[29,32,34,36,38],{"measure":30,"description":31,"timeFrame":12},"Describe the clinical outcomes","according to disease stage",{"measure":30,"description":33,"timeFrame":12},"according to surgical timing",{"measure":30,"description":35,"timeFrame":12},"according to residual disease after surgery in each cohort",{"measure":37,"description":37,"timeFrame":12},"Describe the clinical characteristics of patients for which the combination therapy was offered (Cohort A)",{"measure":39,"description":39,"timeFrame":12},"Describe the treatment approach to HRP patients in a real word scenario in Italy (Cohort B)",null,{"allocation":40,"interventionModel":40,"interventionModelDescription":40,"primaryPurpose":40,"observationalModel":42,"timePerspective":6,"maskingInfo":40},"COHORT","This is a retrospective and prospective, multicenter, observational, two-cohorts study aimed to evaluate clinical outcomes and safety of patients diagnosed with advanced high grade ovarian cancer whose tumor was tested for the homologous recombination status using a validated HRD test between January 2021 and January 2026:\n\nCohort A: Homologous Recombination Deficient (HRD) ovarian cancer patients treated with Olaparib plus Bevacizumab as maintenance therapies after partial or complete response to first line platinum-based chemotherapy.\n\nCohort B: Homologous Recombination Proficient (HRP) ovarian cancer patients treated as for standard clinical practice at clinician's choice. Alive patients who have finished the first line treatment (including maintenance) with or without disease progression while signing the informed consent form will be enrolled retrospectively. Alive patients candidate to receive a first line therapy will be enrolledprospectively as soon as molecular data (BRCA status and HRD) are available.","All patients diagnosed with advanced high grade ovarian cancer who have received a homologous recombination analysis using validated HRD test between January 2021 and January 2026 are eligible. Patients resulted HRD and treated with Olaparib plus Bevacizumab will be included in Cohort A while patient with HRP tumors will be included in the Cohort B. Patients enrolled in the \"compassionate use\" of Olaparib (CNN program) can be included as well as patients who have received therapies according to clinical practice.",[46,49],{"label":47,"type":40,"description":48,"interventionNames":40},"Cohort A: Homologous Recombination Deficient (HRD)","Homologous Recombination Deficient (HRD) ovarian cancer patients treated with Olaparib plus Bevacizumab as maintenance therapies after partial or complete response to first line platinum-based chemotherapy.",{"label":50,"type":40,"description":51,"interventionNames":40},"Cohort B: Homologous Recombination Proficient (HRP)","Homologous Recombination Proficient (HRP) ovarian cancer patients treated as for standard clinical practice at clinician's choice.",[53,59],{"name":54,"role":55,"phone":56,"phoneExt":57,"email":58},"Michele B Michele Bartoletti, MD","CONTACT","+39 334 500 7736","334 500 7736","michele.bartoletti@cro.it",{"name":60,"role":55,"phone":40,"phoneExt":40,"email":61},"BeLIVE S BeLIVE Service","belive@cr-technology.com",[63,82,97,111,126,141,156,170,185,200,211,226,241,254,269,280,294,309,324,339,353],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Istituto Tumori \"Giovanni Paolo II\" I.R.C.C.S.","RECRUITING","Bari","BA","70124","Italy","IT",{"type":72,"coordinates":73},"Point",[74,75],16.86982,41.12066,{"lat":75,"lon":74},[78],{"name":79,"role":55,"phone":80,"phoneExt":80,"email":81},"Gennaro C Gennaro Cormio, MD","080 5555910","gennaro.cormio@uniba.it",{"facility":83,"status":65,"city":84,"state":85,"zip":86,"country":69,"countryCode":70,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Azienda Ospedaliero Universitaria di Bologna - Policlinico S.Orsola-Malpighi","Bologna","BO","40138",{"type":72,"coordinates":88},[89,90],11.33875,44.49381,{"lat":90,"lon":89},[93],{"name":94,"role":55,"phone":95,"phoneExt":95,"email":96},"Claudio Z Claudio Zamagni, MD","051 6361259","claudio.zamagni@aosp.bo.it",{"facility":98,"status":65,"city":99,"state":100,"zip":101,"country":69,"countryCode":70,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Azienda Ospedaliera S.Croce e Carle Cuneo","Cuneo","CN","12100",{"type":72,"coordinates":103},[104,105],7.54828,44.39071,{"lat":105,"lon":104},[108],{"name":109,"role":55,"phone":40,"phoneExt":40,"email":110},"Lorenza P Lorenza Palmero, MD","Palmero.l@ospedale.cuneo.it",{"facility":112,"status":65,"city":113,"state":114,"zip":115,"country":69,"countryCode":70,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Azienda Ospedaliera per l'emergenza Cannizzaro","Catania","CT","95100",{"type":72,"coordinates":117},[118,119],15.07041,37.49223,{"lat":119,"lon":118},[122],{"name":123,"role":55,"phone":124,"phoneExt":124,"email":125},"Giuseppa S Giuseppa Scandurra","09 57264135","giusy.scandurra@gmail.com",{"facility":127,"status":65,"city":128,"state":129,"zip":130,"country":69,"countryCode":70,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) \"Dino Amadori\"","Meldola","FC","47014",{"type":72,"coordinates":132},[133,134],12.0626,44.12775,{"lat":134,"lon":133},[137],{"name":138,"role":55,"phone":139,"phoneExt":139,"email":140},"Alberto F Alberto Farolfi, MD","0543 739100","alberto.farolfi@irst.emr.it",{"facility":142,"status":65,"city":143,"state":144,"zip":145,"country":69,"countryCode":70,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Azienda Ospedaliero Universitario Careggi","Florence","FI","50134",{"type":72,"coordinates":147},[148,149],11.24626,43.77925,{"lat":149,"lon":148},[152],{"name":153,"role":55,"phone":154,"phoneExt":154,"email":155},"Maria Cristina P Maria Cristina Petrella, MD","05 579469171","mariacristina.petrella@gmail.com",{"facility":157,"status":65,"city":158,"state":159,"zip":160,"country":69,"countryCode":70,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"IRCCS Policlinico San Martino","Genova","GE","16132",{"type":72,"coordinates":162},[163,164],11.87211,45.21604,{"lat":164,"lon":163},[167],{"name":168,"role":55,"phone":40,"phoneExt":40,"email":169},"Serafina M Serafina Mammoliti, MD","serafina.mammoliti@hsanmartino.it",{"facility":171,"status":172,"city":173,"state":174,"zip":175,"country":69,"countryCode":70,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"Fondazione IRCCS San Gerardo dei Tintori (Monza)","NOT_YET_RECRUITING","Monza","MB","20900",{"type":72,"coordinates":177},[178,179],9.27246,45.58005,{"lat":179,"lon":178},[182],{"name":183,"role":55,"phone":40,"phoneExt":40,"email":184},"Robert F Robert Fruscio, MD","robert.fruscio@unimib.it",{"facility":186,"status":65,"city":187,"state":188,"zip":189,"country":69,"countryCode":70,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"Università Vita-Salute San Raffaele (IRCCS San Raffaele - Milano)","Milan","MI","20132",{"type":72,"coordinates":191},[192,193],12.59836,42.78235,{"lat":193,"lon":192},[196],{"name":197,"role":55,"phone":198,"phoneExt":198,"email":199},"Alice B Alice Bergamini, MD","022 643 5595","bergamini.alice@unisr.it",{"facility":201,"status":65,"city":187,"state":188,"zip":202,"country":69,"countryCode":70,"cosmosGeoPoint":203,"geoPoint":205,"contacts":206},"Istituto Nazionale Tumori (INT) - Milano","20133",{"type":72,"coordinates":204},[192,193],{"lat":193,"lon":192},[207],{"name":208,"role":55,"phone":209,"phoneExt":209,"email":210},"Mara M Mara Mantiero, MD","02 23902507","mara.mantiero@istitutotumori.mi.it",{"facility":212,"status":65,"city":213,"state":214,"zip":215,"country":69,"countryCode":70,"cosmosGeoPoint":216,"geoPoint":220,"contacts":221},"Istituto Oncologico Veneto (IOV)","Padova","PD","35128",{"type":72,"coordinates":217},[218,219],11.14261,44.38225,{"lat":219,"lon":218},[222],{"name":223,"role":55,"phone":224,"phoneExt":224,"email":225},"Giulia T Giulia Tasca, MD","04 98215931","giulia.tasca@iov.veneto.it",{"facility":227,"status":65,"city":228,"state":229,"zip":230,"country":69,"countryCode":70,"cosmosGeoPoint":231,"geoPoint":235,"contacts":236},"Ospedale S. Maria della Misericordia","Perugia","PG","06156",{"type":72,"coordinates":232},[233,234],12.38878,43.1122,{"lat":234,"lon":233},[237],{"name":238,"role":55,"phone":239,"phoneExt":239,"email":240},"Annamaria M Annamaria Mosconi, MD","07 55784099","annamaria.mosconi@ospedale.perugia.it",{"facility":242,"status":65,"city":243,"state":244,"zip":245,"country":69,"countryCode":70,"cosmosGeoPoint":246,"geoPoint":250,"contacts":251},"Centro di riferimento oncologico - CRO di Aviano","Aviano","PN","33081",{"type":72,"coordinates":247},[248,249],12.59472,46.07056,{"lat":249,"lon":248},[252],{"name":54,"role":55,"phone":56,"phoneExt":253,"email":58},"+39 334 500 77",{"facility":255,"status":65,"city":256,"state":257,"zip":258,"country":69,"countryCode":70,"cosmosGeoPoint":259,"geoPoint":263,"contacts":264},"Istituto Nazionale Tumori Regina Elena - Roma","Roma","RM","00144",{"type":72,"coordinates":260},[261,262],11.10642,44.99364,{"lat":262,"lon":261},[265],{"name":266,"role":55,"phone":267,"phoneExt":267,"email":268},"Antonella S Antonella Savarese, MD","06 52666919","antonella.savarese@ifo.it",{"facility":270,"status":65,"city":256,"state":257,"zip":271,"country":69,"countryCode":70,"cosmosGeoPoint":272,"geoPoint":274,"contacts":275},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","00168",{"type":72,"coordinates":273},[261,262],{"lat":262,"lon":261},[276],{"name":277,"role":55,"phone":278,"phoneExt":278,"email":279},"Claudia M Claudia Marchetti, MD","06 30158556","claudia.marchetti@policlinicogemelli.it",{"facility":281,"status":65,"city":282,"state":283,"zip":284,"country":69,"countryCode":70,"cosmosGeoPoint":285,"geoPoint":289,"contacts":290},"Ospedale San Paolo - ASL2 - Savona","Savona","SV","17100",{"type":72,"coordinates":286},[287,288],8.47715,44.30905,{"lat":288,"lon":287},[291],{"name":292,"role":55,"phone":40,"phoneExt":40,"email":293},"Sara Elena R Sara Elena Rebuzzi","se.rebuzzi@asl2.liguria.it",{"facility":295,"status":65,"city":296,"state":297,"zip":298,"country":69,"countryCode":70,"cosmosGeoPoint":299,"geoPoint":303,"contacts":304},"Ospedale Mauriziano Umberto I","Torino","TO","10128",{"type":72,"coordinates":300},[301,302],11.99138,44.88856,{"lat":302,"lon":301},[305],{"name":306,"role":55,"phone":307,"phoneExt":307,"email":308},"Giorgio V Giorgio Valabrega, MD","+39 0115082046","giorgio.valabrega@unito.it",{"facility":310,"status":65,"city":311,"state":312,"zip":313,"country":69,"countryCode":70,"cosmosGeoPoint":314,"geoPoint":318,"contacts":319},"Azienda sanitaria universitaria Friuli Centrale (ASU FC)","Udine","UD","33100",{"type":72,"coordinates":315},[316,317],13.23715,46.0693,{"lat":317,"lon":316},[320],{"name":321,"role":55,"phone":322,"phoneExt":322,"email":323},"Claudia A Claudia Andreetta, MD","04 32552754","claudia.andreetta@asufc.sanita.fvg.it",{"facility":325,"status":65,"city":326,"state":327,"zip":328,"country":69,"countryCode":70,"cosmosGeoPoint":329,"geoPoint":333,"contacts":334},"Azienda Ulss 3 Serenissima","Mestre","VE","30174",{"type":72,"coordinates":330},[331,332],12.24538,45.49167,{"lat":332,"lon":331},[335],{"name":336,"role":55,"phone":337,"phoneExt":337,"email":338},"Alessandra B Alessandra Baldoni, MD","041 5794002","alessandra.baldoni@aulss3.veneto.it",{"facility":340,"status":65,"city":341,"state":40,"zip":342,"country":69,"countryCode":70,"cosmosGeoPoint":343,"geoPoint":347,"contacts":348},"Istituto Nazionale Tumori IRCCS \"Fondazione G. Pascale","Naples","80131",{"type":72,"coordinates":344},[345,346],14.26811,40.85216,{"lat":346,"lon":345},[349],{"name":350,"role":55,"phone":351,"phoneExt":351,"email":352},"Sabrina Chiara C Sabrina Chiara Cecere, MD","081 1777 0472","s.cecere@istitutotumori.na.it",{"facility":354,"status":65,"city":341,"state":40,"zip":342,"country":69,"countryCode":70,"cosmosGeoPoint":355,"geoPoint":357,"contacts":358},"Università degli Studi di Napoli \"Federico II\"",{"type":72,"coordinates":356},[345,346],{"lat":346,"lon":345},[359],{"name":360,"role":55,"phone":361,"phoneExt":361,"email":362},"Roberto B Roberto Bianco, MD","081 7461111","robianco@unina.it",{"type":364,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100580355","measure-of-outcomes-in-patients-with-advanced-ovarian-cancer-according-to-homologous-recombination-status-and-matched-therapies-in-a-real-world-scenario-100580355",false,"NCT06836219","Measure of Outcomes in Patients With Advanced Ovarian Cancer According to Homologous Recombination Status and Matched Therapies in a Real-world Scenario","Measure of Outcomes in Patients With Advanced Ovarian Cancer According to Homologous Recombination Status and Matched Therapies in a Real-world Scenario: A Retrospective and Prospective, Multicenter, Two Cohorts Study","BeLIVE","Inclusion Criteria:\n\n* Female, age ≥ 18 years at the time of diagnosis\n* Patients diagnosed with high-grade serous or endometroid ovarian, fallopian tube, or primary peritoneal cancer undergone to Homologous Recombination test with the MyChoice HRD assay, FoundationOne DX assay or another validated HRD test, between January 2021 and January 2026:\n\n  * Patients with HRD score \\> 42 or Loss of Heterozygosity (LOH) score high or defined as HR deficient with other tests and treated with Bevacizumab and Olaparib after first line platinumbased chemotherapy will be retrospectively or prospectively enrolled in Cohort A\n  * Patients with HRD score \\\u003C 42 or Loss of Heterozygosity (LOH) score low or defined as HR proficient with other tests and treated with first line platinum-based chemotherapy with or without bevacizumab or others targeted agents will be retrospectively or prospectively enrolled in Cohort B\n* Patients must be able to understand the study procedures and agree to participate in the study by providing written informed consent.\n\nExclusion Criteria:\n\n* Patients who have not performed a validated Homologous Recombination test on tumor sample.\n* Patients with germline or somatic BRCA 1 or 2 mutations\n* Patients death at the time of inclusion in the current study","FEMALE","18 Years",{"count":376,"type":377},300,"ESTIMATED","OBSERVATIONAL","This is a retrospective and prospective, multicenter, observational, two-cohorts study aimed to evaluate clinical outcomes and safety of patients diagnosed with advanced high grade ovarian cancer whose tumor was tested for the homologous recombination (HR) status using a validated HR deficiency test between January 2021 and January 2026.\n\n* Cohort A: Homologous Recombination Deficient (HRD) ovarian cancer patients treated with Olaparib plus Bevacizumab as maintenance therapies after partial or complete response to first line platinum-based chemotherapy.\n* Cohort B: Homologous Recombination Proficient (HRP) ovarian cancer patients treated as for standard clinical practice at clinician's choice.",[381],"Ovarian Cancer",[381,383],"Homologous Recombination status","2025-02-14",{"date":386,"type":387},"2025-02-20","ACTUAL",{"date":389,"type":387},"2024-09-13",{"date":391,"type":377},"2029-01",{"name":5,"class":6},21]