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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

882 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-09

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast cancer

745 patients with HER2-positive and triple-negative breast cancer who underwent neoadjuvant therapy followed by breast surgery.

whole exome and whole genome sequencing analysis

Intervention Type DIAGNOSTIC_TEST

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

whole exome and whole genome sequencing analysis

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

* Men aged ≥ 18 years;
* Confirmed histological diagnosis of prostate adenocarcinoma;
* AJCC 8th edition clinical stage IV;
* Patients must provide written informed consent.