Onco-Genomas Brasil: Mapping Breast and Prostate Cancer in the Brazilian Public Health System
Recruiting
Observational Study
Breast CancerProstate Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
882 (estimated)
Sponsor
Hospital Moinhos de Vento · Other
Who this trial is looking for
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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.
Trial Locations
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Status
Eligibility Criteria
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…
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.
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