Breast CancerNCT05306600
Onco-Genomas Brasil: Mapping Breast and Prostate Cancer in the Brazilian Public Health System
An observational study of Breast Cancer and Prostate Cancer, run by Hospital Moinhos de Vento at 25 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Prostate Cancer
- What is being tested?
- whole exome and whole genome sequencing analysis
- How many people
- 882 participants
- Where
- 25 sitesBrazil
- Study dates
- 9 Nov 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
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- 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.
Who cannot join
- No available paraffin-embedded tumor tissue for genomic analysis;
- Inability to collect blood for genomic evaluation.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Brazil25 sites
Hospital do Amor
Barretos, São Paulo
Hospital Ophir Loyola
Belém, Pará
Hospital Universitário João de Barros Barreto
Belém, Pará
Hospital da Santa Casa de Misericórdia
Belo Horizonte, Minas Gerais
Hospital das Clínicas
Belo Horizonte, Minas Gerais
Hospital Universitário de Brasília
Brasília, Federal District
Hospital Universitário Maria Aparecida Pedrossian
Campo Grande, 79080-190
Hospital do Câncer/União Oeste Paranaense de Estudo e Combate ao Câncer
Cascavel, Paraná, 85.806-300
Hospital Araújo Jorge
Goiânia, 74605-070
Hospital Calixto Midlej Filho/ Santa Casa de Itabuna
Itabuna, Estado de Bahia
Hospital do Câncer de Londrina
Londrina, Paraná
Fundação Centro de Controle de Oncologia do Estado do Amazonas
Manaus, Amazonas
Hospital Universitário Getúlio Vargas
Manaus, Amazonas
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte
Hospital Escola da Universidade Federal de Pelotas
Pelotas, Rio Grande do Sul
Hospital de Clínicas de Porto Alegre
Porto Alegre, 90035-903
Hospital São Lucas da PUCRS
Porto Alegre, 90610-001
Grupo Hospitalar Conceição
Porto Alegre, 91350-200
Hospital Fêmina
Porto Alegre
Instituto Nacional do Câncer (INCA)
Rio de Janeiro
Hospital do Câncer do Maranhão
São Luís, Maranhão
Hospital São Camilo
São Paulo, 04015-070
Hospital Santa Rita de Cássia - AFECC
Vitória, Espírito Santo
Hospital Universitário Cassiano Antônio de Moraes
Vitória, 29043-260
Serviço de Assistência Médica e Urgência S.A. SAMUR
Vitória da Conquista, Estado de Bahia
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Prostate Cancer
- Being tested
- whole exome and whole genome sequencing analysis
- Keywords
- breast cancer, prostate cancer, exome
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole exome and whole genome sequencing analysisDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer | 745 patients with HER2-positive and triple-negative breast cancer who underwent neoadjuvant therapy followed by breast surgery. Receives: Diagnostic Test: whole exome and whole genome sequencing analysis | |
| Prostate cancer | 137 patients with metastatic prostate cancer Receives: Diagnostic Test: whole exome and whole genome sequencing analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize complete somatic and germline exomes/genomes in a Brazilian population
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
Measured: 12 months
Secondary outcomes (3)
To identify genetic variants related to tumor prognosis
Mutations in the somatic and germline exomes/genomes will be correlated to clinical outcomes
Measured: 12 months
To identify genetic variants predictive of response to treatments
Mutations in the somatic and germline exomes/genomes will be correlated to response to treatments
Measured: 12 months
Number of patients with mutations in cancer-predisposing genes
Identify mutations in germline exomes/genomes related to hereditary cancer syndromes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start9 Nov 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 882 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Moinhos de Vento
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Responsible party
- Sponsor
- Investigators
- Daniela D Rosa, PhD, Principal investigator, Hospital Moinhos de Vento
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306600
- Sponsor's protocol ID
- 55457122.3.0000.5330
- Status last verified
- Aug 2026
- First submitted
- 9 Mar 2022
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38544834
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onco-Genomas Brasil: Mapping Breast and Prostate Cancer in the Brazilian Public Health System
- ClinicalTrials.gov ID
- NCT05306600
- Acronym / sponsor ID
- 55457122.3.0000.5330
- Conditions
- Breast Cancer, Prostate Cancer
- Keywords
- breast cancer, prostate cancer, exome
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 882 participants (actual)
- Lead sponsor
- Hospital Moinhos de VentoUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast cancer | – | Diagnostic Test: whole exome and whole genome sequencing analysis745 patients with HER2-positive and triple-negative breast cancer who underwent neoadjuvant therapy followed by breast surgery. |
| Prostate cancer | – | Diagnostic Test: whole exome and whole genome sequencing analysis137 patients with metastatic prostate cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (2 listed)
- No available paraffin-embedded tumor tissue for genomic analysis;
- Inability to collect blood for genomic evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whole exome and whole genome sequencing analysisSomatic 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 | Diagnostic test | Breast cancer, Prostate cancer |
Primary outcome
To characterize complete somatic and germline exomes/genomes in a Brazilian population
Time frame: 12 months
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
3 secondary outcomes
To identify genetic variants related to tumor prognosis
Time frame: 12 months
To identify genetic variants predictive of response to treatments
Time frame: 12 months
Number of patients with mutations in cancer-predisposing genes
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Derived from this study: PubMed 38544834Schuch 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela D Rosa, PhD principal investigator
Hospital Moinhos de Vento
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Prostate Cancer, run by Hospital Moinhos de Vento at 25 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterize complete somatic and germline exomes/genomes in a Brazilian population (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05306600, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.