Onco-Genomas Brasil: Mapping Breast and Prostate Cancer in the Brazilian Public Health System
August 24, 2026 updated by: Hospital Moinhos de Vento
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
882
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Campo Grande, Brazil, 79080-190
- Hospital Universitário Maria Aparecida Pedrossian
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Goiânia, Brazil, 74605-070
- Hospital Araujo Jorge
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Porto Alegre, Brazil, 90035-903
- Hospital de Clínicas de Porto Alegre
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Porto Alegre, Brazil
- Hospital Fêmina
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Porto Alegre, Brazil, 90610-001
- Hospital Sao Lucas da PUCRS
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Porto Alegre, Brazil, 91350-200
- Grupo Hospitalar Conceição
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Rio de Janeiro, Brazil
- Instituto Nacional do Câncer (INCA)
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São Paulo, Brazil, 04015-070
- Hospital São Camilo
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Vitória, Brazil, 29043-260
- Hospital Universitário Cassiano Antônio de Moraes
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Amazonas
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Manaus, Amazonas, Brazil
- Fundação Centro de Controle de Oncologia do Estado do Amazonas
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Manaus, Amazonas, Brazil
- Hospital Universitário Getúlio Vargas
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Espírito Santo
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Vitória, Espírito Santo, Brazil
- Hospital Santa Rita de Cássia - AFECC
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Estado de Bahia
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Itabuna, Estado de Bahia, Brazil
- Hospital Calixto Midlej Filho/ Santa Casa de Itabuna
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Vitória da Conquista, Estado de Bahia, Brazil
- Serviço de Assistência Médica e Urgência S.A. SAMUR
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Federal District
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Brasília, Federal District, Brazil
- Hospital Universitario de Brasilia
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Maranhão
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São Luís, Maranhão, Brazil
- Hospital do Câncer do Maranhão
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil
- Hospital da Santa Casa de Misericórdia
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Belo Horizonte, Minas Gerais, Brazil
- Hospital das Clínicas
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Paraná
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Cascavel, Paraná, Brazil, 85.806-300
- Hospital do Câncer/União Oeste Paranaense de Estudo e Combate ao Câncer
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Londrina, Paraná, Brazil
- Hospital do Câncer de Londrina
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Pará
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Belém, Pará, Brazil
- Hospital Ophir Loyola
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Belém, Pará, Brazil
- Hospital Universitário João de Barros Barreto
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brazil
- Liga Norte Riograndense Contra o Câncer
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Rio Grande do Sul
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Pelotas, Rio Grande do Sul, Brazil
- Hospital Escola da Universidade Federal de Pelotas
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São Paulo
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Barretos, São Paulo, Brazil
- Hospital do Amor
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Breast cancer
745 patients with HER2-positive and triple-negative breast cancer who underwent neoadjuvant therapy followed by breast surgery.
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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 |
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Prostate cancer
137 patients with metastatic prostate cancer
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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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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To characterize complete somatic and germline exomes/genomes in a Brazilian population
Time Frame: 12 months
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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
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To identify genetic variants related to tumor prognosis
Time Frame: 12 months
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Mutations in the somatic and germline exomes/genomes will be correlated to clinical outcomes
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12 months
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To identify genetic variants predictive of response to treatments
Time Frame: 12 months
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Mutations in the somatic and germline exomes/genomes will be correlated to response to treatments
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12 months
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Number of patients with mutations in cancer-predisposing genes
Time Frame: 12 months
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Identify mutations in germline exomes/genomes related to hereditary cancer syndromes
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12 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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To identify the ancestry of patients with breast and prostate cancer
Time Frame: 12 months
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Characterize the genomic ancestry of Brazilian patients with breast and prostate cancer
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Daniela D Rosa, PhD, Hospital Moinhos de Vento
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 9, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
March 9, 2022
First Submitted That Met QC Criteria
March 22, 2022
First Posted (Actual)
April 1, 2022
Study Record Updates
Last Update Posted (Actual)
August 26, 2026
Last Update Submitted That Met QC Criteria
August 24, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 55457122.3.0000.5330
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.