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Clinical Trials in Brazil / NCT05306600
Active, not recruiting Observational

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

NCT05306600 · tracked via the Priya Life Science Brazil tracker
Sponsor
Hospital Moinhos de Vento
Phase
Observational
Started
2022-11-09
Last updated
2026-08-26

Condition(s) studied

Breast CancerProstate Cancer

Investigational drug(s) / intervention(s)

whole exome and whole genome sequencing analysis

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

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (25)

FacilityCityRegionStatus
Fundação Centro de Controle de Oncologia do Estado do Amazonas Manaus Amazonas
Hospital Universitário Getúlio Vargas Manaus Amazonas
Hospital Santa Rita de Cássia - AFECC Vitória Espírito Santo
Hospital Calixto Midlej Filho/ Santa Casa de Itabuna Itabuna Estado de Bahia
Serviço de Assistência Médica e Urgência S.A. SAMUR Vitória da Conquista Estado de Bahia
Hospital Universitário de Brasília Brasília Federal District
Hospital do Câncer do Maranhão São Luís Maranhão
Hospital da Santa Casa de Misericórdia Belo Horizonte Minas Gerais
Hospital das Clínicas Belo Horizonte Minas Gerais
Hospital do Câncer/União Oeste Paranaense de Estudo e Combate ao Câncer Cascavel Paraná
Hospital do Câncer de Londrina Londrina Paraná
Hospital Ophir Loyola Belém Pará
Hospital Universitário João de Barros Barreto Belém Pará
Liga Norte Riograndense Contra o Câncer Natal Rio Grande do Norte
Hospital Escola da Universidade Federal de Pelotas Pelotas Rio Grande do Sul
Hospital do Amor Barretos São Paulo
Hospital Universitário Maria Aparecida Pedrossian Campo Grande Brazil
Hospital Araújo Jorge Goiânia Brazil
Hospital de Clínicas de Porto Alegre Porto Alegre Brazil
Hospital São Lucas da PUCRS Porto Alegre Brazil
Grupo Hospitalar Conceição Porto Alegre Brazil
Hospital Fêmina Porto Alegre Brazil
Instituto Nacional do Câncer (INCA) Rio de Janeiro Brazil
Hospital São Camilo São Paulo Brazil
Hospital Universitário Cassiano Antônio de Moraes Vitória Brazil

More Hospital Moinhos de Vento trials in Brazil

Neuromuscular Electrical Stimulation in a Patient on Invasive Mechanical Ventilation (MOVCARE) Recruiting
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Evaluation of an Active Surveillance Protocol for Prostate Cancer in the Brazilian Population Active, not recruiting
Polypill and RiscOMeter to Prevent StrOke and CogniTive ImpairmEnt (PROMOTE) Recruiting
Randomization to Extend Stroke Intravenous ThromboLysis In Evolving Non-Large Vessel Occlusion With TNK (RESILIENT Recruiting

Other trials for the same condition

Hypofractionated Radiotherapy in Breast Cancer Patients With Prosthetic Reconstruction Recruiting
A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer Active, not recruiting
Evaluation of Sequencing of Anthracyclines and Taxanes for Locally Advanced HER2-negative Breast Cancer Active, not recruiting
CRYoablation for Small Tumors As Local Treatment - SIX Trial Recruiting
A Study of Tobemstomig + Nab-Paclitaxel Compared With Pembrolizumab + Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05306600 on ClinicalTrials.gov ↗ ← All trials in Brazil