Onco-Genomas Brasil: Mapping Breast and Prostate Cancer in the Brazilian Public Health System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: whole exome and whole genome sequencing analysis.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Prostate Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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.
Interventions
- 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 Somatic whole exome and germline whole genome sequencing will be analyzed for triple-negative breast cancer
Primary outcome measures
- To characterize complete somatic and germline exomes/genomes in a Brazilian population [Time frame: 12 months]
Secondary outcome measures (3)
- To identify genetic variants related to tumor prognosis [Time frame: 12 months]
- To identify genetic variants predictive of response to treatments [Time frame: 12 months]
- Number of patients with mutations in cancer-predisposing genes [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Brazil · 25 centers
- Fundação Centro de Controle de Oncologia do Estado do Amazonas — Manaus
- Hospital Universitário Getúlio Vargas — Manaus
- Hospital Santa Rita de Cássia - AFECC — Vitória
- Hospital Calixto Midlej Filho/ Santa Casa de Itabuna — Itabuna
- Serviço de Assistência Médica e Urgência S.A. SAMUR — Vitória da Conquista
- Hospital Universitário de Brasília — Brasília
- Hospital do Câncer do Maranhão — São Luís
- Hospital da Santa Casa de Misericórdia — Belo Horizonte
- … and 17 more centers
Publications
- 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 38544834
Identifiers
NCT: NCT05306600 · 55457122.3.0000.5330