Clinical trial · Observational
Onco-Genomas Brasil: Mapping Breast and Prostate Cancer in the Brazilian Public Health System
NCT05306600CI-TRIAL-00123960active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| whole exome and whole genome sequencing analysis | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Breast cancer
- description
- 745 patients with HER2-positive and triple-negative breast cancer who underwent neoadjuvant therapy followed by breast surgery.
- interventionNames
- Diagnostic Test: whole exome and whole genome sequencing analysis
- label
- Prostate cancer
- description
- 137 patients with metastatic prostate cancer
- interventionNames
- Diagnostic Test: whole exome and whole genome sequencing analysis
Primary outcomes (1)
- measure
- To characterize complete somatic and germline exomes/genomes in a Brazilian population
- timeFrame
- 12 months
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDSchuch JB, Bordignon C, Rosa ML, de Baumont AC, Bessel M, Macedo GS, Rosa DD. Mapping breast and prostate cancer in the Brazilian public health system: study protocol of the Onco-Genomas Brasil. Front Oncol. 2024 Mar 13;14:1350162. doi: 10.3389/fonc.2024.1350162. eCollection 2024. PMID 38544834