Endometrial CancerMADONNANCT06014580
Molecular and Epidemiological Characteristics of Endometrial Cancer in Brazil
An observational study of Endometrial Cancer, run by Latin American Cooperative Oncology Group at 10 sites in Brazil.
Trial summary
An evaluation of the molecular and epidemiological aspects of endometrial cancer in Brazil is necessary to understand the high frequency of advanced disease. A better understanding of the current situation will generate essential data for the future development of national or international cooperative programs that… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Observational study
- How many people
- 276 participants
- Where
- 10 sitesBrazil
- Study dates
- 27 Nov 2023to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women diagnosed with endometrial cancer between January 2016 and December 2019 at participating research sites.
Who may be able to join
- Women ≥18 years
- Histological diagnosis of endometrial carcinoma.
- Diagnosis of endometrial cancer between January 2016 and December 2019.
- FIGO (International Federation of Gynecology and Obstetrics, 2018) Stage I - IV.
- Site and investigator with access to a medical record chart from which data can be abstracted.
- Presence of a sample of tumor tissue (primary tumor or metastasis) available for biomarker testing.
Who cannot join
- Noninvasive endometrial cancer.
- Patients with a history of concurrent or previously treated non-endometrial malignancies except for appropriately treated 1) non -metastatic non-melanoma skin cancer and/or 2) non-metastatic low-grade thyroid tumors and/or 3) in situ carcinomas, including cervix, colon, and skin.
- Nonepithelial histology (leiomyosarcoma, adenosarcoma, endometrial stromal sarcoma, undifferentiated sarcoma, or other mesenchymal tumors.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Brazil10 sites
Hospital Evangélico de Cachoeiro de Itapemirim - Centro de Pesquisas Clínicas em Oncologia (CPCO)
Cachoeiro de Itapemirim, Espírito Santo, 29.308-065
Clinica Prognóstica - Centro de Pesquisa Clínica Onconeo
Campo Grande, Mato Grosso do Sul, 79.002-061
UOPECCAN - Hospital do Câncer de Cascavel
Cascavel, Santa Catarina, 85.806-300
Santa Casa de Misericórdia de Feira de Santana
Feira de Santana, Estado de Bahia
ICC - Instituto do Câncer do Ceará
Fortaleza, Ceará, 60.430-230
Hospital Napoleão Laureano
João Pessoa, Paraíba, 58013-140
INCA - Instituto Nacional de Câncer
Rio de Janeiro, Rio de Janeiro, 20.230-130
Hospital de Oncologia do Maranhão Dr. Tarquínio Lopes Filho
São Luís, Maranhão, 65015-460
BP - A Beneficência Portuguesa de São Paulo
São Paulo, São Paulo, 01323-030
Instituto do Câncer Brasil - Unidade Três Lagoas
Três Lagoas, Mato Grosso do Sul, 79.601-001
About this study
An evaluation of the molecular and epidemiological aspects of endometrial cancer in Brazil is necessary to understand the high frequency of advanced disease. A better understanding of the current situation will generate essential data for the future development of national or international cooperative programs that aim to improve outcomes in these patients and generate additional knowledge for much-needed clinical trials in this population.
Read the detailed description
This is a retrospective observational cohort study. In this study, we will include patients diagnosed with endometrium cancer from January 2016 to December 2019 in participating sites and collect data on demographics, clinicopathological characteristics, treatment patterns, and outcomes. Data will be collected from medical records in selected centers that comprise different regions of Brazil.
The patient data sources will be the medical records of the patients. Patients will continue to receive treatment and clinical evaluations for endometrial cancer according to what is determined by their medical team, according to the usual standards of treatment and clinical practice of each center. To minimize patient selection bias, physicians should invite all consecutive eligible patients.
This study also provides for the collection and archiving of tumor tissue material. The samples will be tested to characterize the molecular subtype of endometrial cancer and will be sequentially stored in a biorepository to enable future translational studies, according to national regulations.
- Conditions
- Endometrial Cancer
- Being tested
- Observational study
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with endometrial cancer | Patients diagnosed with endometrial cancer between January 2016 and December 2019 at participating sites will be included. Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiological Characteristics of the Brazilian Population with Endometrial Cancer
This measure encompasses key epidemiological factors of the Brazilian population diagnosed with endometrial cancer, including age distribution, racial and ethnic demographics, geographic regions, and relevant comorbidities. These details will provide insights into the demographic makeup of the study population.
Measured: At the time of diagnosis.
Molecular Profile Analysis of Endometrial Cancer Cases
This measure focuses on analyzing the molecular profile of endometrial cancer cases in the Brazilian population. It includes information about specific genetic mutations, biomarkers, and molecular subtypes that are relevant to endometrial cancer. Understanding the molecular landscape can contribute to insights into disease progression and potential targeted therapies.
Measured: Throughout the study period, an average of 36 month.
Treatment Patterns for Endometrial Cancer in Brazil
This measure examines the treatment patterns employed for endometrial cancer within the Brazilian population. It includes details about types of treatments received, such as surgery, chemotherapy, radiation therapy, and hormonal therapy. Additionally, it explores the utilization of targeted therapies or immunotherapies.
Measured: From diagnosis to completion of treatment, between January 2016 and December 2019.
Endometrial Cancer Outcomes in the Brazilian Population
This measure assesses the outcomes of endometrial cancer cases in the Brazilian population. It includes survival rates, disease recurrence rates, response to treatment, and overall disease progression. By evaluating these outcomes, a comprehensive understanding of the disease's impact on the population can be achieved.
Measured: From diagnosis to the end of the study follow-up period, an average of 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start27 Nov 2023
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial 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
- Retrospective
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latin American Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Andreia Cristina de Melo, Principal investigator, Latin American Cooperative Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014580
- Sponsor's protocol ID
- LACOG 0521
- Acronym
- MADONNA
- Status last verified
- Aug 2026
- First submitted
- 15 Jun 2023
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular and Epidemiological Characteristics of Endometrial Cancer in Brazil
- ClinicalTrials.gov ID
- NCT06014580
- Acronym / sponsor ID
- MADONNA / LACOG 0521
- Conditions
- Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Latin American Cooperative Oncology GroupUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 28 Aug 2023 (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.
An evaluation of the molecular and epidemiological aspects of endometrial cancer in Brazil is necessary to understand the high frequency of advanced disease. A better understanding of the current situation will generate essential data for the future development of national or international cooperative programs that aim to improve outcomes in these patients and generate additional knowledge for much-needed clinical trials in this population.
Detailed description
This is a retrospective observational cohort study. In this study, we will include patients diagnosed with endometrium cancer from January 2016 to December 2019 in participating sites and collect data on demographics, clinicopathological characteristics, treatment patterns, and outcomes. Data will be collected from medical records in selected centers that comprise different regions of Brazil.
The patient data sources will be the medical records of the patients. Patients will continue to receive treatment and clinical evaluations for endometrial cancer according to what is determined by their medical team, according to the usual standards of treatment and clinical practice of each center. To minimize patient selection bias, physicians should invite all consecutive eligible patients.
This study also provides for the collection and archiving of tumor tissue material. The samples will be tested to characterize the molecular subtype of endometrial cancer and will be sequentially stored in a biorepository to enable future translational studies, according to national regulations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with endometrial cancer | – | Other: Observational studyPatients diagnosed with endometrial cancer between January 2016 and December 2019 at participating sites will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women diagnosed with endometrial cancer between January 2016 and December 2019 at participating research sites.
Key inclusion criteria (6 listed)
- Women ≥18 years
- Histological diagnosis of endometrial carcinoma.
- Diagnosis of endometrial cancer between January 2016 and December 2019.
- FIGO (International Federation of Gynecology and Obstetrics, 2018) Stage I - IV.
- Site and investigator with access to a medical record chart from which data can be abstracted.
Key exclusion criteria (3 listed)
- Noninvasive endometrial cancer.
- Patients with a history of concurrent or previously treated non-endometrial malignancies except for appropriately treated 1) non -metastatic non-melanoma skin cancer and/or 2) non-metastatic low-grade thyroid tumors and/or 3) in situ carcinomas, including cervix, colon, and skin.
- Nonepithelial histology (leiomyosarcoma, adenosarcoma, endometrial stromal sarcoma, undifferentiated sarcoma, or other mesenchymal tumors.
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 |
|---|---|---|
| Observational studyThis is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care. | Other | Patients diagnosed with endometrial cancer |
Primary outcome
Epidemiological Characteristics of the Brazilian Population with Endometrial Cancer
Time frame: At the time of diagnosis.
This measure encompasses key epidemiological factors of the Brazilian population diagnosed with endometrial cancer, including age distribution, racial and ethnic demographics, geographic regions, and relevant comorbidities. These details will provide insights into the demographic makeup of the study population.
Molecular Profile Analysis of Endometrial Cancer Cases
Time frame: Throughout the study period, an average of 36 month.
This measure focuses on analyzing the molecular profile of endometrial cancer cases in the Brazilian population. It includes information about specific genetic mutations, biomarkers, and molecular subtypes that are relevant to endometrial cancer. Understanding the molecular landscape can contribute to insights into disease progression and potential targeted therapies.
Treatment Patterns for Endometrial Cancer in Brazil
Time frame: From diagnosis to completion of treatment, between January 2016 and December 2019.
This measure examines the treatment patterns employed for endometrial cancer within the Brazilian population. It includes details about types of treatments received, such as surgery, chemotherapy, radiation therapy, and hormonal therapy. Additionally, it explores the utilization of targeted therapies or immunotherapies.
Endometrial Cancer Outcomes in the Brazilian Population
Time frame: From diagnosis to the end of the study follow-up period, an average of 36 months.
This measure assesses the outcomes of endometrial cancer cases in the Brazilian population. It includes survival rates, disease recurrence rates, response to treatment, and overall disease progression. By evaluating these outcomes, a comprehensive understanding of the disease's impact on the population can be achieved.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- 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.
Andreia Cristina de Melo principal investigator
Latin American Cooperative Oncology Group
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by Latin American Cooperative Oncology Group at 10 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 27 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 10 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Epidemiological Characteristics of the Brazilian Population with Endometrial Cancer (time frame: At the time of diagnosis.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2026.