Onco-Genomas Brasil: Mapping Breast and Prostate Cancer in the Brazilian Public Health System

February 12, 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

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 (Estimated)

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 Contact

Study Locations

  • Brazil
      • Campo Grande, Brazil, 79080-190
        • Recruiting
        • Hospital Universitário Maria Aparecida Pedrossian
        • Principal Investigator:
          • Henrique G Ascenço
      • Goiânia, Brazil, 74605-070
        • Recruiting
        • Hospital Araujo Jorge
        • Principal Investigator:
          • Ruffo Freitas Jr.
      • Porto Alegre, Brazil, 90035-903
        • Recruiting
        • Hospital De Clinicas De Porto Alegre
        • Principal Investigator:
          • Pedro ER Liedke
      • Porto Alegre, Brazil, 90610-001
        • Recruiting
        • Hospital Sao Lucas da PUCRS
        • Principal Investigator:
          • Gustavo Werutsky
      • Porto Alegre, Brazil, 91350-200
        • Recruiting
        • Grupo Hospitalar Conceição
        • Principal Investigator:
          • Juliana J Menezes
      • Porto Alegre, Brazil
        • Recruiting
        • Hospital Fêmina
        • Principal Investigator:
          • Christina PO Kussler
      • Rio de Janeiro, Brazil
        • Recruiting
        • Instituto Nacional Do Cancer (INCA)
      • São Paulo, Brazil, 04015-070
        • Recruiting
        • Hospital São Camilo
        • Principal Investigator:
          • Lilian AR Barros
      • Vitória, Brazil, 29043-260
        • Recruiting
        • Hospital Universitario Cassiano Antonio de Moraes
        • Principal Investigator:
          • Vitor F Vasconcellos
    • Amazonas
      • Manaus, Amazonas, Brazil
        • Recruiting
        • Hospital Universitário Getúlio Vargas
        • Principal Investigator:
          • André Mancini
      • Manaus, Amazonas, Brazil
        • Recruiting
        • Fundação Centro de Controle de Oncologia do Estado do Amazonas
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil
        • Recruiting
        • Hospital Santa Rita de Cássia - AFECC
        • Principal Investigator:
          • Gláucio A Bertollo
    • Estado de Bahia
      • Itabuna, Estado de Bahia, Brazil
        • Recruiting
        • Hospital Calixto Midlej Filho/ Santa Casa de Itabuna
        • Principal Investigator:
          • Eduardo K Neto
      • Vitória da Conquista, Estado de Bahia, Brazil
        • Recruiting
        • Serviço de Assistência Médica e Urgência S.A. SAMUR
    • Federal District
      • Brasília, Federal District, Brazil
        • Recruiting
        • Hospital Universitario de Brasilia
    • Maranhão
      • São Luís, Maranhão, Brazil
        • Recruiting
        • Hospital do Câncer do Maranhão
        • Principal Investigator:
          • Daniela L Louzeiro
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil
        • Recruiting
        • Hospital da Santa Casa de Misericórdia
        • Principal Investigator:
          • Flávio Brandão
      • Belo Horizonte, Minas Gerais, Brazil
        • Recruiting
        • Hospital das Clinicas
        • Principal Investigator:
          • Angélica N Rodrigues
    • Paraná
      • Cascavel, Paraná, Brazil, 85.806-300
        • Recruiting
        • Hospital do Câncer/União Oeste Paranaense de Estudo e Combate ao Câncer
        • Principal Investigator:
          • Aline BL Gongora
      • Londrina, Paraná, Brazil
        • Recruiting
        • Hospital do Cancer de Londrina
    • Pará
      • Belém, Pará, Brazil
        • Recruiting
        • Hospital Universitário João de Barros Barreto
        • Principal Investigator:
          • Williams F Barra
      • Belém, Pará, Brazil
        • Recruiting
        • Hospital Ophir Loyola
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil
        • Recruiting
        • Liga Norte Riograndense Contra O Cancer
        • Principal Investigator:
          • Edilmar M Santos
    • Rio Grande do Sul
      • Pelotas, Rio Grande do Sul, Brazil
        • Recruiting
        • Hospital Escola da Universidade Federal de Pelotas
        • Principal Investigator:
          • Alessandra Notari
    • São Paulo
      • Barretos, São Paulo, Brazil
        • Recruiting
        • Hospital do Amor
        • Principal Investigator:
          • Cristiano P Souza

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.
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
Prostate cancer
137 patients with metastatic prostate cancer
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To characterize complete somatic and germline exomes/genomes in a Brazilian population
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
To identify genetic variants related to tumor prognosis
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
Identify mutations in germline exomes/genomes related to hereditary cancer syndromes
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To identify the ancestry of patients with breast and prostate cancer
Time Frame: 12 months
Characterize the genomic ancestry of Brazilian patients with breast and prostate cancer
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Moinhos de Vento

Collaborators

Ministry of Health, Brazil

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.

General Publications

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)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 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.

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