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| Name | Class |
|---|---|
| Ministry of Health, Brazil | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast cancer | 745 patients with HER2-positive and triple-negative breast cancer who underwent neoadjuvant therapy followed by breast surgery. |
| |
| Prostate cancer | 137 patients with metastatic prostate cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| whole exome and whole genome sequencing analysis | Diagnostic Test | Somatic and germline whole exome sequencing will be analyzed for prostate and HER2-positive breast cancer Somatic whole exome and germline whole genome sequencing will be analyzed for triple-negative breast cancer |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize complete somatic and germline exomes/genomes in a Brazilian population | Mutations in the somatic and germline exomes/genomes of women with HER2-positive and triple-negative breast cancer and of men with metastatic prostate cancer will be described | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| To identify genetic variants related to tumor prognosis | Mutations in the somatic and germline exomes/genomes will be correlated to clinical outcomes | 12 months |
| To identify genetic variants predictive of response to treatments |
| Measure | Description | Time Frame |
|---|---|---|
| To identify the ancestry of patients with breast and prostate cancer | Characterize the genomic ancestry of Brazilian patients with breast and prostate cancer | 12 months |
Inclusion criteria for breast cancer patients (Arm 1):
Inclusion criteria for patients with prostate cancer (Arm 2):
Exclusion criteria for Arms 1 and 2:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marina Bessel | Contact | +555135378345 | marina.bessel@hmv.org.br |
| Name | Affiliation | Role |
|---|---|---|
| Daniela D Rosa, PhD | Hospital Moinhos de Vento | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundação Centro de Controle de Oncologia do Estado do Amazonas | Recruiting | Manaus | Amazonas | Brazil | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38544834 | Derived | Schuch JB, Bordignon C, Rosa ML, de Baumont AC, Bessel M, Macedo GS, Rosa DD. Mapping breast and prostate cancer in the Brazilian public health system: study protocol of the Onco-Genomas Brasil. Front Oncol. 2024 Mar 13;14:1350162. doi: 10.3389/fonc.2024.1350162. eCollection 2024. |
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Whole blood and formalin-fixed paraffin-embedded (FFPE) tissue
|
Mutations in the somatic and germline exomes/genomes will be correlated to response to treatments
| 12 months |
| Number of patients with mutations in cancer-predisposing genes | Identify mutations in germline exomes/genomes related to hereditary cancer syndromes | 12 months |
| Hospital Universitário Getúlio Vargas |
| Recruiting |
| Manaus |
| Amazonas |
| Brazil |
|
| Hospital Santa Rita de Cássia - AFECC | Recruiting | Vitória | Espírito Santo | Brazil |
|
| Hospital Calixto Midlej Filho/ Santa Casa de Itabuna | Recruiting | Itabuna | Estado de Bahia | Brazil |
|
| Serviço de Assistência Médica e Urgência S.A. SAMUR | Recruiting | Vitória da Conquista | Estado de Bahia | Brazil |
| Hospital Universitário de Brasília | Recruiting | Brasília | Federal District | Brazil |
| Hospital do Câncer do Maranhão | Recruiting | São Luís | Maranhão | Brazil |
|
| Hospital da Santa Casa de Misericórdia | Recruiting | Belo Horizonte | Minas Gerais | Brazil |
|
| Hospital das Clínicas | Recruiting | Belo Horizonte | Minas Gerais | Brazil |
|
| Hospital do Câncer/União Oeste Paranaense de Estudo e Combate ao Câncer | Recruiting | Cascavel | Paraná | 85.806-300 | Brazil |
|
| Hospital do Câncer de Londrina | Recruiting | Londrina | Paraná | Brazil |
| Hospital Ophir Loyola | Recruiting | Belém | Pará | Brazil |
| Hospital Universitário João de Barros Barreto | Recruiting | Belém | Pará | Brazil |
|
| Liga Norte Riograndense Contra o Câncer | Recruiting | Natal | Rio Grande do Norte | Brazil |
|
| Hospital Escola da Universidade Federal de Pelotas | Recruiting | Pelotas | Rio Grande do Sul | Brazil |
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| Hospital do Amor | Recruiting | Barretos | São Paulo | Brazil |
|
| Hospital Universitário Maria Aparecida Pedrossian | Recruiting | Campo Grande | 79080-190 | Brazil |
|
| Hospital Araújo Jorge | Recruiting | Goiânia | 74605-070 | Brazil |
|
| Hospital de Clínicas de Porto Alegre | Recruiting | Porto Alegre | 90035-903 | Brazil |
|
| Hospital São Lucas da PUCRS | Recruiting | Porto Alegre | 90610-001 | Brazil |
|
| Grupo Hospitalar Conceição | Recruiting | Porto Alegre | 91350-200 | Brazil |
|
| Hospital Fêmina | Recruiting | Porto Alegre | Brazil |
|
| Instituto Nacional do Câncer (INCA) | Recruiting | Rio de Janeiro | Brazil |
| Hospital São Camilo | Recruiting | São Paulo | 04015-070 | Brazil |
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| Hospital Universitário Cassiano Antônio de Moraes | Recruiting | Vitória | 29043-260 | Brazil |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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