Status:
RECRUITING
Onco-Genomas Brasil: Mapping Breast and Prostate Cancer in the Brazilian Public Health System
Lead Sponsor:
Hospital Moinhos de Vento
Collaborating Sponsors:
Ministry of Health, Brazil
Conditions:
Breast Cancer
Prostate Cancer
Eligibility:
All Genders
18+ years
Brief 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 gene...
Detailed 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 occu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 9 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
882 Patients enrolled
Trial Details
Trial ID
NCT05306600
Start Date
November 9 2022
End Date
December 31 2026
Last Update
May 22 2024
Active Locations (19)
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1
Hospital Universitário Getúlio Vargas
Manaus, Amazonas, Brazil
2
Hospital Santa Rita de Cássia - AFECC
Vitória, Espírito Santo, Brazil
3
Hospital Calixto Midlej Filho/ Santa Casa de Itabuna
Itabuna, Estado de Bahia, Brazil
4
Hospital do Câncer do Maranhão
São Luís, Maranhão, Brazil