Onco-Genomas Brasil: Mapping Breast and Prostate Cancer in the Brazilian Public Health System
Recruiting · NCT05306600 · Observational (researchers observe without assigning treatment) · Lead sponsor: Hospital Moinhos de Vento
View the official record on ClinicalTrials.gov →Interventions studied
whole exome and whole genome sequencing analysis
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- for breast cancer patients (Arm 1):
- Women aged ≥ 18 years;
- Brazilian nationality;
- 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 \<1% and no overexpression of HER2);
- 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;
- 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;
- Triple-negative patients: must undergo neoadjuvant chemotherapy without immunotherapy in the following regimens: anthracycline (doxorubicin or epirubicin) followed by taxane (docetaxel or paclitaxel) with/ without platins (carboplatin ou cisplatin) or a regimen without anthracycline (taxane with/without platins)
- Patients must provide written informed consent prior to inclusion
- Inclusion criteria for patients with prostate cancer (Arm 2):
- Men aged ≥ 18 years;
- Confirmed histological diagnosis of prostate adenocarcinoma;
- AJCC 8th edition clinical stage IV;
- Patients must provide written informed consent.
Exclusion criteria
- for Arms 1 and 2:
- No available paraffin-embedded tumor tissue for genomic analysis;
- Inability to collect blood for genomic evaluation.
Where it is running
50 locations listed.
- Hospital Universitário Maria Aparecida Pedrossian - Campo Grande, Brazil
- Hospital Universitário Maria Aparecida Pedrossian - Campo Grande, Brazil
- Hospital Araújo Jorge - Goiânia, Brazil
- Hospital Araújo Jorge - Goiânia, Brazil
- Hospital de Clínicas de Porto Alegre - Porto Alegre, Brazil
- Hospital São Lucas da PUCRS - Porto Alegre, Brazil
- Grupo Hospitalar Conceição - Porto Alegre, Brazil
- Hospital Fêmina - Porto Alegre, Brazil
- Hospital de Clínicas de Porto Alegre - Porto Alegre, Brazil
- Hospital São Lucas da PUCRS - Porto Alegre, Brazil
- Grupo Hospitalar Conceição - Porto Alegre, Brazil
- Hospital Fêmina - Porto Alegre, Brazil
- Instituto Nacional do Câncer (INCA) - Rio de Janeiro, Brazil
- Instituto Nacional do Câncer (INCA) - Rio de Janeiro, Brazil
- Hospital São Camilo - São Paulo, Brazil
- Hospital São Camilo - São Paulo, Brazil
- Hospital Universitário Cassiano Antônio de Moraes - Vitória, Brazil
- Hospital Universitário Cassiano Antônio de Moraes - Vitória, Brazil
- Fundação Centro de Controle de Oncologia do Estado do Amazonas - Manaus, Amazonas, Brazil
- Hospital Universitário Getúlio Vargas - Manaus, Amazonas, Brazil
- Fundação Centro de Controle de Oncologia do Estado do Amazonas - Manaus, Amazonas, Brazil
- Hospital Universitário Getúlio Vargas - Manaus, Amazonas, Brazil
- Hospital Santa Rita de Cássia - AFECC - Vitória, Espírito Santo, Brazil
- Hospital Santa Rita de Cássia - AFECC - Vitória, Espírito Santo, Brazil
- Hospital Calixto Midlej Filho/ Santa Casa de Itabuna - Itabuna, Estado de Bahia, Brazil
- Hospital Calixto Midlej Filho/ Santa Casa de Itabuna - Itabuna, Estado de Bahia, Brazil
- Serviço de Assistência Médica e Urgência S.A. SAMUR - Vitória da Conquista, Estado de Bahia, Brazil
- Serviço de Assistência Médica e Urgência S.A. SAMUR - Vitória da Conquista, Estado de Bahia, Brazil
- Hospital Universitário de Brasília - Brasília, Federal District, Brazil
- Hospital Universitário de Brasília - Brasília, Federal District, Brazil
- Hospital do Câncer do Maranhão - São Luís, Maranhão, Brazil
- Hospital do Câncer do Maranhão - São Luís, Maranhão, Brazil
- Hospital da Santa Casa de Misericórdia - Belo Horizonte, Minas Gerais, Brazil
- Hospital das Clínicas - Belo Horizonte, Minas Gerais, Brazil
- Hospital da Santa Casa de Misericórdia - Belo Horizonte, Minas Gerais, Brazil
- Hospital das Clínicas - Belo Horizonte, Minas Gerais, Brazil
- Hospital do Câncer/União Oeste Paranaense de Estudo e Combate ao Câncer - Cascavel, Paraná, Brazil
- Hospital do Câncer/União Oeste Paranaense de Estudo e Combate ao Câncer - Cascavel, Paraná, Brazil
- Hospital do Câncer de Londrina - Londrina, Paraná, Brazil
- Hospital do Câncer de Londrina - Londrina, Paraná, Brazil
- Hospital Ophir Loyola - Belém, Pará, Brazil
- Hospital Universitário João de Barros Barreto - Belém, Pará, Brazil
- Hospital Ophir Loyola - Belém, Pará, Brazil
- Hospital Universitário João de Barros Barreto - Belém, Pará, Brazil
- Liga Norte Riograndense Contra o Câncer - Natal, Rio Grande do Norte, Brazil
- Liga Norte Riograndense Contra o Câncer - Natal, Rio Grande do Norte, Brazil
- Hospital Escola da Universidade Federal de Pelotas - Pelotas, Rio Grande do Sul, Brazil
- Hospital Escola da Universidade Federal de Pelotas - Pelotas, Rio Grande do Sul, Brazil
- Hospital do Amor - Barretos, São Paulo, Brazil
- Hospital do Amor - Barretos, São Paulo, Brazil