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

Last updated: May 21, 2024
Sponsor: Hospital Moinhos de Vento
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Urologic Cancer

Prostate Cancer, Early, Recurrent

Treatment

whole exome sequencing analysis

whole exome and whole genome sequencing analysis

Clinical Study ID

NCT05306600
55457122.3.0000.5330
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 882
Treatment Group(s): 2
Primary Treatment: whole exome sequencing analysis
Phase:
Study Start date:
November 09, 2022
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Hospital Universitário Getúlio Vargas

    Manaus, Amazonas
    Brazil

    Active - Recruiting

  • Hospital Calixto Midlej Filho/ Santa Casa de Itabuna

    Itabuna, Bahia
    Brazil

    Active - Recruiting

  • Hospital Santa Rita de Cássia - AFECC

    Vitória, Espírito Santo
    Brazil

    Active - Recruiting

  • Hospital do Câncer do Maranhão

    São Luís, Maranhão
    Brazil

    Active - Recruiting

  • Hospital da Santa Casa de Misericórdia

    Belo Horizonte, Minas Gerais
    Brazil

    Active - Recruiting

  • Hospital das Clínicas

    Belo Horizonte, Minas Gerais
    Brazil

    Active - Recruiting

  • Hospital do Câncer/União Oeste Paranaense de Estudo e Combate ao Câncer

    Cascavel, Paraná 85.806-300
    Brazil

    Active - Recruiting

  • Hospital Universitário João de Barros Barreto

    Belém, Pará
    Brazil

    Active - Recruiting

  • Liga Norte Riograndense Contra o Câncer

    Natal, Rio Grande Do Norte
    Brazil

    Active - Recruiting

  • Hospital Escola da Universidade Federal de Pelotas

    Pelotas, Rio Grande Do Sul
    Brazil

    Active - Recruiting

  • Hospital do Amor

    Barretos, São Paulo
    Brazil

    Active - Recruiting

  • Hospital Universitário Maria Aparecida Pedrossian

    Campo Grande, 79080-190
    Brazil

    Active - Recruiting

  • Hospital Araújo Jorge

    Goiânia, 74605-070
    Brazil

    Active - Recruiting

  • Grupo Hospitalar Conceição

    Porto Alegre, 91350-200
    Brazil

    Active - Recruiting

  • Hospital Fêmina

    Porto Alegre,
    Brazil

    Active - Recruiting

  • Hospital São Lucas da PUCRS

    Porto Alegre, 90610-001
    Brazil

    Active - Recruiting

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, 90035-903
    Brazil

    Active - Recruiting

  • Hospital São Camilo

    São Paulo, 04015-070
    Brazil

    Active - Recruiting

  • Hospital Universitário Cassiano Antônio de Moraes

    Vitória, 29043-260
    Brazil

    Active - Recruiting

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