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Идёт набор NCT05306600

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

— Наблюдательное Breast Cancer Prostate Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: whole exome and whole genome sequencing analysis.
Кому может быть актуально
Состояния в реестре: Breast Cancer, Prostate Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бразилия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

  • Диагностический тест 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

Первичные конечные точки

  • To characterize complete somatic and germline exomes/genomes in a Brazilian population [Срок оценки: 12 months]
Вторичные конечные точки (3)
  • To identify genetic variants related to tumor prognosis [Срок оценки: 12 months]
  • To identify genetic variants predictive of response to treatments [Срок оценки: 12 months]
  • Number of patients with mutations in cancer-predisposing genes [Срок оценки: 12 months]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Бразилия · 25 центров
  • Fundação Centro de Controle de Oncologia do Estado do Amazonas — Manaus
  • Hospital Universitário Getúlio Vargas — Manaus
  • Hospital Santa Rita de Cássia - AFECC — Vitória
  • Hospital Calixto Midlej Filho/ Santa Casa de Itabuna — Itabuna
  • Serviço de Assistência Médica e Urgência S.A. SAMUR — Vitória da Conquista
  • Hospital Universitário de Brasília — Brasília
  • Hospital do Câncer do Maranhão — São Luís
  • Hospital da Santa Casa de Misericórdia — Belo Horizonte
  • … и ещё 17 центров

Публикации

  • Schuch 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

Идентификаторы

NCT: NCT05306600 · 55457122.3.0000.5330

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗