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Onco-Genomas Brasil: Mapping Breast and Prostate Cancer in the Brazilian Public Health System
Bu çalışma, Brezilya kamu sağlık sistemindeki meme kanseri (breast cancer) ve prostat kanseri (prostate cancer) hastalarında tüm ekzom ve tüm genom dizileme analizleriyle genetik özellikleri haritalamayı amaçlamaktadır. Çalışmaya, HER2 pozitif veya üçlü negatif meme kanseri olan 18 yaş üzeri kadınlar ve ileri evre prostat adenokarsinomu olan erkekler alınmaktadır. Faz uygulanmayan bir çalışma olup halen katılımcı almaktadır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
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.