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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05306600
• Other study ID #: 55457122.3.0000.5330
• Status: Recruiting
• Start date: November 9, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: Hospital Moinhos de Vento
• Contact: Marina Bessel
• Phone: +555135378345
• Email: marina.bessel[@]hmv.org.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 882
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital do Amor	Barretos	São Paulo
Brazil	Hospital Universitário João de Barros Barreto	Belém	Pará
Brazil	Hospital da Santa Casa de Misericórdia	Belo Horizonte	Minas Gerais
Brazil	Hospital das Clínicas	Belo Horizonte	Minas Gerais
Brazil	Hospital Universitário Maria Aparecida Pedrossian	Campo Grande
Brazil	Hospital do Câncer/União Oeste Paranaense de Estudo e Combate ao Câncer	Cascavel	Paraná
Brazil	Hospital Araújo Jorge	Goiânia
Brazil	Hospital Calixto Midlej Filho/ Santa Casa de Itabuna	Itabuna	Bahia
Brazil	Hospital Universitário Getúlio Vargas	Manaus	Amazonas
Brazil	Liga Norte Riograndense Contra o Câncer	Natal	Rio Grande Do Norte
Brazil	Hospital Escola da Universidade Federal de Pelotas	Pelotas	Rio Grande Do Sul
Brazil	Grupo Hospitalar Conceição	Porto Alegre
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre
Brazil	Hospital Fêmina	Porto Alegre
Brazil	Hospital São Lucas da PUCRS	Porto Alegre
Brazil	Hospital do Câncer do Maranhão	São Luís	Maranhão
Brazil	Hospital São Camilo	São Paulo
Brazil	Hospital Santa Rita de Cássia - AFECC	Vitória	Espírito Santo
Brazil	Hospital Universitário Cassiano Antônio de Moraes	Vitória

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Moinhos de Vento	Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To identify the ancestry of patients with breast and prostate cancer	Characterize the genomic ancestry of Brazilian patients with breast and prostate cancer	12 months
Primary	To characterize complete somatic and germline exomes/genomes in a Brazilian population	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	To identify genetic variants related to tumor prognosis	Mutations in the somatic and germline exomes/genomes will be correlated to clinical outcomes	12 months
Secondary	To identify genetic variants predictive of response to treatments	Mutations in the somatic and germline exomes/genomes will be correlated to response to treatments	12 months
Secondary	Number of patients with mutations in cancer-predisposing genes	Identify mutations in germline exomes/genomes related to hereditary cancer syndromes	12 months