Clinical trial NCT05306600: Onco-Genomas Brasil: Mapping Breast and Prostate Cancer in the Brazilian Public Health System
Official title: Onco-Genomas Brasil: Mapping Breast and Prostate Cancer in the Brazilian Public Health System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Prostate Cancer
Keywords: breast cancer
prostate cancer
exome
Lead sponsor: Hospital Moinhos de Vento
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2022-04-01
Enrollment: 882
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Institutions from each region that serve Public Health System patients and have high complexity oncology care centers will be included in both Arms to provide a sample that represents the heterogeneity of the Brazilian population. Institutions previously evaluated and validated by the Brazilian Ministry of Health will be selected after completing a feasibility questionnaire. It is estimated that 25 to 30 institutions will be included (at least one from each region) in Arm 1. For Arm 2, 10 centers will be selected from among previously approved institutions.

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 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.

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 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.

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-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.

Primary outcomes:
measure: To characterize complete somatic and germline exomes/genomes in a Brazilian population
timeFrame: 12 months
Secondary outcomes:
measure: To identify genetic variants related to tumor prognosis
timeFrame: 12 months
measure: To identify genetic variants predictive of response to treatments
timeFrame: 12 months
measure: Number of patients with mutations in cancer-predisposing genes
timeFrame: 12 months
Other outcomes:
measure: To identify the ancestry of patients with breast and prostate cancer
timeFrame: 12 months
Locations:
city: Manaus
country: Brazil
facility: Hospital Universitário Getúlio Vargas
state: Amazonas
city: Itabuna
country: Brazil
facility: Hospital Calixto Midlej Filho/ Santa Casa de Itabuna
state: Bahia
city: Vitória
country: Brazil
facility: Hospital Santa Rita de Cássia - AFECC
state: Espírito Santo
city: São Luís
country: Brazil
facility: Hospital do Câncer do Maranhão
state: Maranhão
city: Belo Horizonte
country: Brazil
facility: Hospital da Santa Casa de Misericórdia
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Hospital das Clínicas
state: Minas Gerais
city: Cascavel
country: Brazil
facility: Hospital do Câncer/União Oeste Paranaense de Estudo e Combate ao Câncer
state: Paraná
city: Belém
country: Brazil
facility: Hospital Universitário João de Barros Barreto
state: Pará
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Câncer
state: Rio Grande Do Norte
city: Pelotas
country: Brazil
facility: Hospital Escola da Universidade Federal de Pelotas
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Hospital do Amor
state: São Paulo
city: Campo Grande
country: Brazil
facility: Hospital Universitário Maria Aparecida Pedrossian
city: Goiânia
country: Brazil
facility: Hospital Araújo Jorge
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
city: Porto Alegre
country: Brazil
facility: Grupo Hospitalar Conceição
city: Porto Alegre
country: Brazil
facility: Hospital Fêmina
city: São Paulo
country: Brazil
facility: Hospital São Camilo
city: Vitória
country: Brazil
facility: Hospital Universitário Cassiano Antônio de Moraes
Study officials:
affiliation: Hospital Moinhos de Vento
name: Daniela D Rosa, PhD
role: PRINCIPAL_INVESTIGATOR
References: