Onco-Genomas Brasil: Mapping Breast and Prostate Cancer in the Brazilian Public Health System
1 other identifier
observational
882
1 country
25
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2022
Longer than P75 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2022
CompletedFirst Posted
Study publicly available on registry
April 1, 2022
CompletedStudy Start
First participant enrolled
November 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
February 13, 2026
February 1, 2026
4.1 years
March 9, 2022
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
To identify genetic variants related to tumor prognosis
12 months
To identify genetic variants predictive of response to treatments
12 months
Number of patients with mutations in cancer-predisposing genes
12 months
Other Outcomes (1)
To identify the ancestry of patients with breast and prostate cancer
12 months
Study Arms (2)
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
Interventions
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
Eligibility Criteria
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.
You may qualify if:
- 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)
- Men aged ≥ 18 years;
- Confirmed histological diagnosis of prostate adenocarcinoma;
- AJCC 8th edition clinical stage IV;
- Patients must provide written informed consent.
You may not qualify if:
- No available paraffin-embedded tumor tissue for genomic analysis;
- Inability to collect blood for genomic evaluation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Moinhos de Ventolead
- Ministry of Health, Brazilcollaborator
Study Sites (25)
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 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
Hospital Universitário de Brasília
Brasília, Federal District, 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 do Câncer/União Oeste Paranaense de Estudo e Combate ao Câncer
Cascavel, Paraná, 85.806-300, Brazil
Hospital do Câncer de Londrina
Londrina, Paraná, 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
Hospital Escola da Universidade Federal de Pelotas
Pelotas, Rio Grande do Sul, Brazil
Hospital do Amor
Barretos, São Paulo, Brazil
Hospital Universitário Maria Aparecida Pedrossian
Campo Grande, 79080-190, Brazil
Hospital Araújo Jorge
Goiânia, 74605-070, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, 90610-001, Brazil
Grupo Hospitalar Conceição
Porto Alegre, 91350-200, Brazil
Hospital Fêmina
Porto Alegre, Brazil
Instituto Nacional do Câncer (INCA)
Rio de Janeiro, Brazil
Hospital São Camilo
São Paulo, 04015-070, Brazil
Hospital Universitário Cassiano Antônio de Moraes
Vitória, 29043-260, Brazil
Related Publications (1)
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.
PMID: 38544834DERIVED
Biospecimen
Whole blood and formalin-fixed paraffin-embedded (FFPE) tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniela D Rosa, PhD
Hospital Moinhos de Vento
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2022
First Posted
April 1, 2022
Study Start
November 9, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 13, 2026
Record last verified: 2026-02