[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100462816":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":31,"studyPopulation":32,"armGroups":33,"interventions":43,"overallOfficials":49,"centralContacts":53,"locations":59,"responsibleParty":318,"collaborators":320,"id":324,"slug":28,"hasResults":325,"nctId":326,"briefTitle":327,"officialTitle":327,"acronym":28,"eligibilityCriteria":328,"healthyVolunteers":325,"sex":329,"minAge":330,"maxAge":28,"enrollmentInfo":331,"targetDuration":28,"studyType":334,"phases":28,"briefSummary":335,"conditions":336,"keywords":339,"overallStatus":62,"whyStopped":28,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":352},{"fullName":5,"class":6},"Hospital Moinhos de Vento","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"To characterize complete somatic and germline exomes\u002Fgenomes in a Brazilian population","Mutations in the somatic and germline exomes\u002Fgenomes of women with HER2-positive and triple-negative breast cancer and of men with metastatic prostate cancer will be described","12 months",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"To identify genetic variants related to tumor prognosis","Mutations in the somatic and germline exomes\u002Fgenomes will be correlated to clinical outcomes",{"measure":18,"description":19,"timeFrame":12},"To identify genetic variants predictive of response to treatments","Mutations in the somatic and germline exomes\u002Fgenomes will be correlated to response to treatments",{"measure":21,"description":22,"timeFrame":12},"Number of patients with mutations in cancer-predisposing genes","Identify mutations in germline exomes\u002Fgenomes related to hereditary cancer syndromes",[24],{"measure":25,"description":26,"timeFrame":12},"To identify the ancestry of patients with breast and prostate cancer","Characterize the genomic ancestry of Brazilian patients with breast and prostate cancer",{"allocation":28,"interventionModel":28,"interventionModelDescription":28,"primaryPurpose":28,"observationalModel":29,"timePerspective":30,"maskingInfo":28},null,"COHORT","PROSPECTIVE","In Brazil, the most frequent types of neoplasm are prostate cancer in men and breast cancer in women. Understanding the molecular variants in tumors, which result from mutations and variants that occur during carcinogenesis, can affect treatment response and disease prognosis and is an important target of oncology research. Detecting hereditary genetic syndromes also helps in oncological follow-up, allowing prediction of the risk of new neoplasms. This project aims to perform complete sequencing of the somatic (tumor) and germline exomes during clinical investigation of cancer patients treated through the Brazilian Unified Health System to generate genomic and phenotypic data for the Brazilian Ministry of Health's National Precision Genomics and Health Program, called Genomas Brasil, as well as to collect data on the population's ancestry.","Institutions from each region that serve Public Health System patients and have high complexity oncology care centers will be included in both Arms to provide a sample that represents the heterogeneity of the Brazilian population. Institutions previously evaluated and validated by the Brazilian Ministry of Health will be selected after completing a feasibility questionnaire. It is estimated that 25 to 30 institutions will be included (at least one from each region) in Arm 1. For Arm 2, 10 centers will be selected from among previously approved institutions.",[34,39],{"label":35,"type":28,"description":36,"interventionNames":37},"Breast cancer","745 patients with HER2-positive and triple-negative breast cancer who underwent neoadjuvant therapy followed by breast surgery.",[38],"Diagnostic Test: whole exome and whole genome sequencing analysis",{"label":40,"type":28,"description":41,"interventionNames":42},"Prostate cancer","137 patients with metastatic prostate cancer",[38],[44],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":28},"DIAGNOSTIC_TEST","whole exome and whole genome sequencing analysis","Somatic and germline whole exome sequencing will be analyzed for prostate and HER2-positive breast cancer\n\nSomatic whole exome and germline whole genome sequencing will be analyzed for triple-negative breast cancer",[35,40],[50],{"name":51,"affiliation":5,"role":52},"Daniela D Rosa, PhD","PRINCIPAL_INVESTIGATOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":28,"email":58},"Marina Bessel","CONTACT","+555135378345","marina.bessel@hmv.org.br",[60,73,81,93,105,113,122,134,146,154,167,175,184,192,204,216,228,240,252,264,273,282,290,298,309],{"facility":61,"status":62,"city":63,"state":64,"zip":28,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":28},"Fundação Centro de Controle de Oncologia do Estado do Amazonas","RECRUITING","Manaus","Amazonas","Brazil","BR",{"type":68,"coordinates":69},"Point",[70,71],-60.025,-3.10194,{"lat":71,"lon":70},{"facility":74,"status":62,"city":63,"state":64,"zip":28,"country":65,"countryCode":66,"cosmosGeoPoint":75,"geoPoint":77,"contacts":78},"Hospital Universitário Getúlio Vargas",{"type":68,"coordinates":76},[70,71],{"lat":71,"lon":70},[79],{"name":80,"role":52,"phone":28,"phoneExt":28,"email":28},"André Mancini",{"facility":82,"status":62,"city":83,"state":84,"zip":28,"country":65,"countryCode":66,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Hospital Santa Rita de Cássia - AFECC","Vitória","Espírito Santo",{"type":68,"coordinates":86},[87,88],-40.33778,-20.31944,{"lat":88,"lon":87},[91],{"name":92,"role":52,"phone":28,"phoneExt":28,"email":28},"Gláucio A Bertollo",{"facility":94,"status":62,"city":95,"state":96,"zip":28,"country":65,"countryCode":66,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Hospital Calixto Midlej Filho\u002F Santa Casa de Itabuna","Itabuna","Estado de Bahia",{"type":68,"coordinates":98},[99,100],-39.28028,-14.78556,{"lat":100,"lon":99},[103],{"name":104,"role":52,"phone":28,"phoneExt":28,"email":28},"Eduardo K Neto",{"facility":106,"status":62,"city":107,"state":96,"zip":28,"country":65,"countryCode":66,"cosmosGeoPoint":108,"geoPoint":112,"contacts":28},"Serviço de Assistência Médica e Urgência S.A. SAMUR","Vitória da Conquista",{"type":68,"coordinates":109},[110,111],-40.83944,-14.86611,{"lat":111,"lon":110},{"facility":114,"status":62,"city":115,"state":116,"zip":28,"country":65,"countryCode":66,"cosmosGeoPoint":117,"geoPoint":121,"contacts":28},"Hospital Universitário de Brasília","Brasília","Federal District",{"type":68,"coordinates":118},[119,120],-47.92972,-15.77972,{"lat":120,"lon":119},{"facility":123,"status":62,"city":124,"state":125,"zip":28,"country":65,"countryCode":66,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Hospital do Câncer do Maranhão","São Luís","Maranhão",{"type":68,"coordinates":127},[128,129],-44.30278,-2.52972,{"lat":129,"lon":128},[132],{"name":133,"role":52,"phone":28,"phoneExt":28,"email":28},"Daniela L Louzeiro",{"facility":135,"status":62,"city":136,"state":137,"zip":28,"country":65,"countryCode":66,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Hospital da Santa Casa de Misericórdia","Belo Horizonte","Minas Gerais",{"type":68,"coordinates":139},[140,141],-43.93778,-19.92083,{"lat":141,"lon":140},[144],{"name":145,"role":52,"phone":28,"phoneExt":28,"email":28},"Flávio Brandão",{"facility":147,"status":62,"city":136,"state":137,"zip":28,"country":65,"countryCode":66,"cosmosGeoPoint":148,"geoPoint":150,"contacts":151},"Hospital das Clínicas",{"type":68,"coordinates":149},[140,141],{"lat":141,"lon":140},[152],{"name":153,"role":52,"phone":28,"phoneExt":28,"email":28},"Angélica N Rodrigues",{"facility":155,"status":62,"city":156,"state":157,"zip":158,"country":65,"countryCode":66,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Hospital do Câncer\u002FUnião Oeste Paranaense de Estudo e Combate ao Câncer","Cascavel","Paraná","85.806-300",{"type":68,"coordinates":160},[161,162],-53.45528,-24.95583,{"lat":162,"lon":161},[165],{"name":166,"role":52,"phone":28,"phoneExt":28,"email":28},"Aline BL Gongora",{"facility":168,"status":62,"city":169,"state":157,"zip":28,"country":65,"countryCode":66,"cosmosGeoPoint":170,"geoPoint":174,"contacts":28},"Hospital do Câncer de Londrina","Londrina",{"type":68,"coordinates":171},[172,173],-51.16278,-23.31028,{"lat":173,"lon":172},{"facility":176,"status":62,"city":177,"state":178,"zip":28,"country":65,"countryCode":66,"cosmosGeoPoint":179,"geoPoint":183,"contacts":28},"Hospital Ophir Loyola","Belém","Pará",{"type":68,"coordinates":180},[181,182],-48.50444,-1.45583,{"lat":182,"lon":181},{"facility":185,"status":62,"city":177,"state":178,"zip":28,"country":65,"countryCode":66,"cosmosGeoPoint":186,"geoPoint":188,"contacts":189},"Hospital Universitário João de Barros Barreto",{"type":68,"coordinates":187},[181,182],{"lat":182,"lon":181},[190],{"name":191,"role":52,"phone":28,"phoneExt":28,"email":28},"Williams F Barra",{"facility":193,"status":62,"city":194,"state":195,"zip":28,"country":65,"countryCode":66,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"Liga Norte Riograndense Contra o Câncer","Natal","Rio Grande do Norte",{"type":68,"coordinates":197},[198,199],-35.20944,-5.795,{"lat":199,"lon":198},[202],{"name":203,"role":52,"phone":28,"phoneExt":28,"email":28},"Edilmar M Santos",{"facility":205,"status":62,"city":206,"state":207,"zip":28,"country":65,"countryCode":66,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Hospital Escola da Universidade Federal de Pelotas","Pelotas","Rio Grande do Sul",{"type":68,"coordinates":209},[210,211],-52.34101,-31.76997,{"lat":211,"lon":210},[214],{"name":215,"role":52,"phone":28,"phoneExt":28,"email":28},"Alessandra Notari",{"facility":217,"status":62,"city":218,"state":219,"zip":28,"country":65,"countryCode":66,"cosmosGeoPoint":220,"geoPoint":224,"contacts":225},"Hospital do Amor","Barretos","São Paulo",{"type":68,"coordinates":221},[222,223],-48.56778,-20.55722,{"lat":223,"lon":222},[226],{"name":227,"role":52,"phone":28,"phoneExt":28,"email":28},"Cristiano P Souza",{"facility":229,"status":62,"city":230,"state":28,"zip":231,"country":65,"countryCode":66,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"Hospital Universitário Maria Aparecida Pedrossian","Campo Grande","79080-190",{"type":68,"coordinates":233},[234,235],-54.64639,-20.44278,{"lat":235,"lon":234},[238],{"name":239,"role":52,"phone":28,"phoneExt":28,"email":28},"Henrique G Ascenço",{"facility":241,"status":62,"city":242,"state":28,"zip":243,"country":65,"countryCode":66,"cosmosGeoPoint":244,"geoPoint":248,"contacts":249},"Hospital Araújo Jorge","Goiânia","74605-070",{"type":68,"coordinates":245},[246,247],-49.25389,-16.67861,{"lat":247,"lon":246},[250],{"name":251,"role":52,"phone":28,"phoneExt":28,"email":28},"Ruffo Freitas Jr.",{"facility":253,"status":62,"city":254,"state":28,"zip":255,"country":65,"countryCode":66,"cosmosGeoPoint":256,"geoPoint":260,"contacts":261},"Hospital de Clínicas de Porto Alegre","Porto Alegre","90035-903",{"type":68,"coordinates":257},[258,259],-51.23019,-30.03283,{"lat":259,"lon":258},[262],{"name":263,"role":52,"phone":28,"phoneExt":28,"email":28},"Pedro ER Liedke",{"facility":265,"status":62,"city":254,"state":28,"zip":266,"country":65,"countryCode":66,"cosmosGeoPoint":267,"geoPoint":269,"contacts":270},"Hospital São Lucas da PUCRS","90610-001",{"type":68,"coordinates":268},[258,259],{"lat":259,"lon":258},[271],{"name":272,"role":52,"phone":28,"phoneExt":28,"email":28},"Gustavo Werutsky",{"facility":274,"status":62,"city":254,"state":28,"zip":275,"country":65,"countryCode":66,"cosmosGeoPoint":276,"geoPoint":278,"contacts":279},"Grupo Hospitalar Conceição","91350-200",{"type":68,"coordinates":277},[258,259],{"lat":259,"lon":258},[280],{"name":281,"role":52,"phone":28,"phoneExt":28,"email":28},"Juliana J Menezes",{"facility":283,"status":62,"city":254,"state":28,"zip":28,"country":65,"countryCode":66,"cosmosGeoPoint":284,"geoPoint":286,"contacts":287},"Hospital Fêmina",{"type":68,"coordinates":285},[258,259],{"lat":259,"lon":258},[288],{"name":289,"role":52,"phone":28,"phoneExt":28,"email":28},"Christina PO Kussler",{"facility":291,"status":62,"city":292,"state":28,"zip":28,"country":65,"countryCode":66,"cosmosGeoPoint":293,"geoPoint":297,"contacts":28},"Instituto Nacional do Câncer (INCA)","Rio de Janeiro",{"type":68,"coordinates":294},[295,296],-43.18223,-22.90642,{"lat":296,"lon":295},{"facility":299,"status":62,"city":219,"state":28,"zip":300,"country":65,"countryCode":66,"cosmosGeoPoint":301,"geoPoint":305,"contacts":306},"Hospital São Camilo","04015-070",{"type":68,"coordinates":302},[303,304],-46.63611,-23.5475,{"lat":304,"lon":303},[307],{"name":308,"role":52,"phone":28,"phoneExt":28,"email":28},"Lilian AR Barros",{"facility":310,"status":62,"city":83,"state":28,"zip":311,"country":65,"countryCode":66,"cosmosGeoPoint":312,"geoPoint":314,"contacts":315},"Hospital Universitário Cassiano Antônio de Moraes","29043-260",{"type":68,"coordinates":313},[87,88],{"lat":88,"lon":87},[316],{"name":317,"role":52,"phone":28,"phoneExt":28,"email":28},"Vitor F Vasconcellos",{"type":319,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[321],{"name":322,"class":323},"Ministry of Health, Brazil","OTHER_GOV","100462816",false,"NCT05306600","Onco-Genomas Brasil: Mapping Breast and Prostate Cancer in the Brazilian Public Health System","Inclusion criteria for breast cancer patients (Arm 1):\n\n* Women aged ≥ 18 years;\n* Brazilian nationality;\n* After review at the Hospital Moinhos de Vento, confirmed histological diagnosis of breast carcinoma with overexpression of HER2 (classified by immunohistochemistry as 3+ or 2+ with positive in-situ hybridization) or triple-negative (estrogen and progesterone receptors \\\u003C1% and no overexpression of HER2);\n* Clinical stage II or III for HER2-positive and I, II and III for triple-negative patients - American Joint Committee on Cancer (AJCC) 8th edition;\n* HER2- positive patients: must undergo neoadjuvant chemotherapy plus trastuzumab in the following regimens: anthracycline (doxorubicin or epirubicin) followed by taxane (docetaxel or paclitaxel), combined with trastuzumab, or a non-anthracycline option consisting of taxane (docetaxel or paclitaxel) combined with carboplatin and trastuzumab;\n* Triple-negative patients: must undergo neoadjuvant chemotherapy without immunotherapy in the following regimens: anthracycline (doxorubicin or epirubicin) followed by taxane (docetaxel or paclitaxel) with\u002F without platins (carboplatin ou cisplatin) or a regimen without anthracycline (taxane with\u002Fwithout platins)\n* Patients must provide written informed consent prior to inclusion\n\nInclusion criteria for patients with prostate cancer (Arm 2):\n\n* Men aged ≥ 18 years;\n* Confirmed histological diagnosis of prostate adenocarcinoma;\n* AJCC 8th edition clinical stage IV;\n* Patients must provide written informed consent.\n\nExclusion criteria for Arms 1 and 2:\n\n* No available paraffin-embedded tumor tissue for genomic analysis;\n* Inability to collect blood for genomic evaluation.","ALL","18 Years",{"count":332,"type":333},882,"ESTIMATED","OBSERVATIONAL","This project aims to perform complete sequencing of the somatic (tumor) and germline exomes during clinical investigation of cancer patients treated through the Brazilian Unified Health System to generate genomic and phenotypic data for the Brazilian Ministry of Health's National Precision Genomics and Health Program, called Genomas Brasil, as well as to collect data on the population's ancestry.",[337,338],"Breast Cancer","Prostate Cancer",[340,341,342],"breast cancer","prostate cancer","exome","2026-02-12",{"date":345,"type":346},"2026-02-13","ACTUAL",{"date":348,"type":346},"2022-11-09",{"date":350,"type":333},"2026-12-31",{"name":5,"class":6},25]