Ovarian Cancer by FIGO StageMOANANCT07771400
Molecular Ovarian Cancer Assessment in LatiNoAmerican PAtients
An observational study of Ovarian Cancer by FIGO Stage and Ovarian Cancer Stage III, run by Latin American Cooperative Oncology Group at 17 sites in 4 countries.
Trial summary
This is a multicentric observational study conducted at selected sites across Latin America. Eligible participants will be identified through the medical records of participating institutions. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer by FIGO Stage, Ovarian Cancer Stage III, Ovarian Cancer Stage IV
- Type of treatment
- Injection or infusion
- How many people
- 320 participants
- Where
- 17 sitesin 4 countries
- Study dates
- Sep 2026to Aug 2027
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of 320 participants aged ≥18 years with a diagnosis of advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (FIGO stage III-IV), including newly diagnosed, persistent, or recurrent disease, identified between 2018 and 2024 at approximately 16 participating centers across Brazil, Mexico, Colombia, and Argentina. Eligible participants must have histologically confirmed serous, endometrioid, mucinous, or clear cell carcinoma.
Who may be able to join
- Participants ≥18 years-old.
- Patients diagnosed with ovarian, fallopian tube or peritoneal cancer:
- advanced stages stage III or IV by FIGO disease stage
- new diagnosis and persistent or recurrent disease
- Diagnosed from 2018 to 2024.
- Histologically confirmed diagnosis of serous (low or high grade), endometrioid, mucinous or clear cell ovarian carcinoma.
- Accept to participate in the project and sign the informed consent (if applicable).
- An archived representative formalin-fixed paraffin-embedded (FFPE) tumor specimen in tumor tissue blocks (preferred) or freshly sectioned unstained slides (at least 20) from biopsy/surgery is mandatory.
Who cannot join
- Histological ambiguous diagnosis upon review.
- Diagnosis based on cytology and without any biopsy or surgical specimen.
- Patients diagnosed and staged but not receiving any treatment.
- Patients without medical records available (lost, empty or irretrievable clinical information).
Trial locations and contacts
17 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 4 countries
Brazil9 sites
Oncocentro de Minas Gerais
Belo Horizonte, Minas Gerais, 30360-680
Angélica Rodrigues, +5531996543307, angelica.onco@uol.com.br
Clínica Prognóstica - Centro de Pesquisa Clínica Onconeo
Campo Grande, Mato Grosso do Sul, 79002-061
Cristina Sampaio, +5567981080610, cristina.anjos@gmail.com
ANIMI - Unidade de Tratamento Oncológico
Lages, Santa Catarina, 88501-001
Maitê Schurmann, +5549991229300, maite.animi@gmail.com
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, 59062-000
Sulene Oliveira, +5584991191032, sulene.cunha@liga.org.br
Futtura Oncologia Hub de Pesquisa Clinica Ltda
Porto Alegre, Rio Grande do Sul, 90470-340
Fernanda Casarotto, +555196667320, FERNANDACASAROTTO@YAHOO.COM.BR
IMIP - Instituto de Medicina Integral Professor Fernando Figueira
Recife, Pernambuco, 50070-902
Carla Azevedo, +5581999297557, carla.rameri@icloud.com
CTTB - Centro de Tratamento de Tumores Botafogo (Oncoclínicas)
Rio de Janeiro, Rio de Janeiro, 22250-905
Alexssandra Santos, +5521988365225, alexssandra.santos@medicos.oncoclinicas.com
Fundação Antonio Prudente - A.C. Camargo Cancer Center
São Paulo, São Paulo, 01509-001
Andrea Guimarães, +5511976480202, andrea.guimaraes@accamargo.org.br
HIAE - Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05653-000
Donato Callegaro, +5511983329926, donato.filho@einstein.br
Argentina3 sites
Hospital Alemán de Buenos Aires
Buenos Aires
Gonzalo Abuin, +541151500619, ggomezabuin@hospitalaleman.com
Instituto Alexander Fleming
Buenos Aires
Gonzalo Gomez, +5491153286427, gonzalogiornelli@gmail.com
Fundación Pita
Rosario
Miriam Raimondo, +5493416448821, miriamraimondo2014@gmail.com
Mexico3 sites
Hospital Ángeles Pedregal
Mexico City
Diego Pérez, +525513602156, medicina.diego.osorio@gmail.com
INCan - Instituto Nacional de Cancerología
Mexico City
Antônio Bahena, +525591856562, antoniobahena@hotmail.com
TecSalud (Tecnológico de Monterrey)
Nuevo León
Omar Peña, +528112776469, dr.omarpena@medicos.tecsalud.mx
Colombia2 sites
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer
Bogotá
Claudia Castro, +573153364563, cruzclaudiac@hotmail.com
Instituto Nacional de Cancerología Colombia
Bogotá
Fernando Mejía, +573102013510, fcontreras@cancer.gov.co
About this study
This is a multicentric observational study conducted at selected sites across Latin America. Eligible participants will be identified through the medical records of participating institutions. The study aims to describe overlap of expression of folate receptor alpha (FRα), HER2 and PD-L1 using immunohistochemistry (IHC) and HRD and BRCA (somatic and germline) by NGS. Additionally, to describe clinical demographic and socioeconomic variables, as well as treatment patterns, pathological characteristics, outcomes, and genetic and molecular testing part of clinical practice.
All data (including patient characteristics, treatment patterns, outcomes and available tests) will be collected once, retrospectively from medical records, ensuring adherence to ethical standards and participant confidentiality. Biomarkers analysis (including FRα, HER2 and PD-L1) will be performed prospectively, a Formalin-Fixed Paraffin-Embedded (FFPE) tumor block will be collected to evaluate and describe the expression of folate receptor alpha (FRα) and HER2, using immunohistochemistry (IHC) with the Roche Ventana kit (FOLR1 and HER2 4B5) and Dako's 22C3 for PD-L1. The study will analyze samples collected between 1st January 2018 to 31 December 2024 (analysis of historically collected samples).
The study comprises a retrospective data collection from medical charts. Participants will continue to receive treatment and clinical evaluations according to what is determined by their medical team, according to the usual standards of treatment and clinical practice of each center. No intervention or prospective follow-up is proposed in this study.
Read the detailed description
The study combines a retrospective collection of clinical, sociodemographic, pathological, and treatment history data from medical records with a prospective laboratory analysis of archived tumor tissue samples collected between 2018 and 2024.
Biomarker Evaluation \& Central Pathology:
Archival formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks or unstained slides will undergo centralized digital pathology review and immunohistochemical (IHC) evaluation to assess expression levels:
- Folate Receptor Alpha (FRa): Assessed using the Roche Ventana FOLR1 assay.
- HER2: Evaluated using the Roche Ventana HER2 (4B5) assay.
- PD-L1: Evaluated using Dako 22C3.
- Additional exploratory IHC markers (ER, PR, MLH1, MSH2, MSH6, PMS2) will also be evaluated.
Genetic and molecular status for BRCA1/2 mutations and Homologous Recombination Deficiency (HRD) obtained via Next-Generation Sequencing (NGS) will be extracted retrospectively from medical records as available in routine clinical practice.
All clinical and historical data will be abstracted once retrospectively from participant charts and recorded electronically using a validated REDCap Electronic Data Capture (EDC) system. The study design involves no prospective clinical follow-up or therapeutic interventions; all participants continue standard-of-care treatment as dictated by their treating physicians.
An interim statistical analysis is planned after 50% of the target sample in Brazil has completed baseline assessments, followed by a final analysis upon full study completion.
- Conditions
- Ovarian Cancer by FIGO Stage, Ovarian Cancer Stage III, Ovarian Cancer Stage IV, Fallopian Tube Cancer Stage III, Fallopian Tube Cancer Stage IV, Fallopian Tube Cancers
- Keywords
- Peritonial Cancer
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Cohort | Patients diagnosed with ovarian, fallopian tube or peritoneal cancer with a) advanced stages stage III or IV by FIGO disease stage b) new diagnosis and persistent or recurrent disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of high-grade serous advanced ovarian cancer (AOC) cases overlapping FRα, HER2, PD-L1 positive expression and aberration positives for HRD and BRCA.
The percentage of high- grade serous AOC cases which are overlapping FRα, HER2, PD-L1 positive expression by IHC according to established clinical cut-offs and aberration positives for HRD and BRCA:
FRα: ≥75% of viable tumour cells with 2+ and 3+ scoring intensity. HER2: ≥10% of viable tumour cells with 3+ staining intensity by IHC using current CAP guidelines for scoring HER2 in gastric cancer.
PD-L1: positive expression is combined positive score (CPS) ≥1 and ≥10. BRCA mutational status: mutated. HRD: positive.
Measured: Data is extracted from retrospective medical records covering cases diagnosed from 2018 to 2024, with no prospective clinical follow-up or therapeutic interventions proposed.
Secondary outcomes (4)
Socio-demographic and clinicopathologic characteristics of Latin American advanced ovarian cancer (AOC) patients.
Description and summarization of socio-demographic and clinicopathologic characteristics (including histological subtypes) of the study population, presented as frequencies and percentages.
Measured: Baseline
Treatment patterns of high-grade serous advanced ovarian cancer (AOC).
Description of treatment patterns by absolute numbers and percentages of patients, including type of treatment (surgery procedures, chemotherapy regimens, target therapies such as bevacizumab-based or PARP inhibitor-based, and best supportive care [BSC]) stratified by line of treatment (first line [1L] and second line [2L] or more) to define the median number of therapies. It also evaluates the time to first treatment, defined as the duration from the high-grade serous AOC diagnosis until the administration of the first treatment.
Measured: Baseline
Folate receptor alpha (FRα), HER2, and PD-L1 expression by histologic advanced ovarian cancer (AOC) subtype.
Evaluation of the percentage (absolute numbers) of ovarian cancer cases expressing FRα, HER2, and PD-L1 by immunohistochemistry (IHC) across different histological groups (Serous [low and high grade], endometrioid, clear cell, and mucinous). FRα expression will be evaluated using the VENTANA FOLR1 kit at two thresholds of viable tumor cells (TC) with membrane staining at moderate (2+) and/or strong (3+) intensity levels: ≥50% and ≥75%.
Measured: Baseline
Mutational status of HRD and BRCA in high-grade serous advanced ovarian cancer (AOC).
Evaluation of the percentage (absolute number) of Latin American patients with high-grade serous AOC exhibiting alterations in homologous recombination deficiency (HRD) status (positive/deficiency vs. negative/proficiency) and BRCA mutational status (mutated vs. wild-type) collected from Next-Generation Sequencing (NGS) data available in medical records.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cancer by FIGO StageStudies 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
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Latin American Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie, EVA - Grupo Brasileiro de Tumores Ginecológicos
- Responsible party
- Sponsor
- Investigators
- Angélica Rodrigues, Principal investigator, Oncocentro de Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771400
- Sponsor's protocol ID
- LACOG 1325
- Acronym
- MOANA
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Ovarian Cancer Assessment in LatiNoAmerican PAtients
- ClinicalTrials.gov ID
- NCT07771400
- Acronym / sponsor ID
- MOANA / LACOG 1325
- Conditions
- Ovarian Cancer by FIGO Stage, Ovarian Cancer Stage III, Ovarian Cancer Stage IV, Fallopian Tube Cancer Stage III, Fallopian Tube Cancer Stage IV, Fallopian Tube Cancers
- Keywords
- Peritonial Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Latin American Cooperative Oncology GroupUniversity, hospital or other
- Collaborators
- AbbVie, EVA - Grupo Brasileiro de Tumores Ginecológicos
- Study start
- Sep 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 18 Aug 2026 (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 is a multicentric observational study conducted at selected sites across Latin America. Eligible participants will be identified through the medical records of participating institutions. The study aims to describe overlap of expression of folate receptor alpha (FRα), HER2 and PD-L1 using immunohistochemistry (IHC) and HRD and BRCA (somatic and germline) by NGS. Additionally, to describe clinical demographic and socioeconomic variables, as well as treatment patterns, pathological characteristics, outcomes, and genetic and molecular testing part of clinical practice.
All data (including patient characteristics, treatment patterns, outcomes and available tests) will be collected once, retrospectively from medical records, ensuring adherence to ethical standards and participant confidentiality. Biomarkers analysis (including FRα, HER2 and PD-L1) will be performed prospectively, a Formalin-Fixed Paraffin-Embedded (FFPE) tumor block will be collected to evaluate and describe the expression of folate receptor alpha (FRα) and HER2, using immunohistochemistry (IHC) with the Roche Ventana kit (FOLR1 and HER2 4B5) and Dako's 22C3 for PD-L1. The study will analyze samples collected between 1st January 2018 to 31 December 2024 (analysis of historically collected samples).
The study comprises a retrospective data collection from medical charts. Participants will continue to receive treatment and clinical evaluations according to what is determined by their medical team, according to the usual standards of treatment and clinical practice of each center. No intervention or prospective follow-up is proposed in this study.
Detailed description
The study combines a retrospective collection of clinical, sociodemographic, pathological, and treatment history data from medical records with a prospective laboratory analysis of archived tumor tissue samples collected between 2018 and 2024.
Biomarker Evaluation \& Central Pathology:
Archival formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks or unstained slides will undergo centralized digital pathology review and immunohistochemical (IHC) evaluation to assess expression levels:
- Folate Receptor Alpha (FRa): Assessed using the Roche Ventana FOLR1 assay.
- HER2: Evaluated using the Roche Ventana HER2 (4B5) assay.
- PD-L1: Evaluated using Dako 22C3.
- Additional exploratory IHC markers (ER, PR, MLH1, MSH2, MSH6, PMS2) will also be evaluated.
Genetic and molecular status for BRCA1/2 mutations and Homologous Recombination Deficiency (HRD) obtained via Next-Generation Sequencing (NGS) will be extracted retrospectively from medical records as available in routine clinical practice.
All clinical and historical data will be abstracted once retrospectively from participant charts and recorded electronically using a validated REDCap Electronic Data Capture (EDC) system. The study design involves no prospective clinical follow-up or therapeutic interventions; all participants continue standard-of-care treatment as dictated by their treating physicians.
An interim statistical analysis is planned after 50% of the target sample in Brazil has completed baseline assessments, followed by a final analysis upon full study completion.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort | – | –Patients diagnosed with ovarian, fallopian tube or peritoneal cancer with a) advanced stages stage III or IV by FIGO disease stage b) new diagnosis and persistent or recurrent disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of 320 participants aged ≥18 years with a diagnosis of advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (FIGO stage III-IV), including newly diagnosed, persistent, or recurrent disease, identified between 2018 and 2024 at approximately 16 participating centers across Brazil, Mexico, Colombia, and Argentina. Eligible participants must have histologically confirmed serous, endometrioid, mucinous, or clear cell carcinoma.
Key inclusion criteria (8 listed)
- Participants ≥18 years-old.
- Patients diagnosed with ovarian, fallopian tube or peritoneal cancer:
- Diagnosed from 2018 to 2024.
- Histologically confirmed diagnosis of serous (low or high grade), endometrioid, mucinous or clear cell ovarian carcinoma.
- Accept to participate in the project and sign the informed consent (if applicable).
Key exclusion criteria (4 listed)
- Histological ambiguous diagnosis upon review.
- Diagnosis based on cytology and without any biopsy or surgical specimen.
- Patients diagnosed and staged but not receiving any treatment.
- Patients without medical records available (lost, empty or irretrievable clinical information).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of high-grade serous advanced ovarian cancer (AOC) cases overlapping FRα, HER2, PD-L1 positive expression and aberration positives for HRD and BRCA.
Time frame: Data is extracted from retrospective medical records covering cases diagnosed from 2018 to 2024, with no prospective clinical follow-up or therapeutic interventions proposed.
The percentage of high- grade serous AOC cases which are overlapping FRα, HER2, PD-L1 positive expression by IHC according to established clinical cut-offs and aberration positives for HRD and BRCA: FRα: ≥75% of viable tumour cells with 2+ and 3+ scoring intensity. HER2: ≥10% of viable tumour cells with 3+ staining intensity by IHC using current CAP guidelines for scoring HER2 in gastric cancer. PD-L1: positive expression is combined positive score (CPS) ≥1 and ≥10. BRCA mutational status: mutated. HRD: positive.
4 secondary outcomes
Socio-demographic and clinicopathologic characteristics of Latin American advanced ovarian cancer (AOC) patients.
Time frame: Baseline
Treatment patterns of high-grade serous advanced ovarian cancer (AOC).
Time frame: Baseline
Folate receptor alpha (FRα), HER2, and PD-L1 expression by histologic advanced ovarian cancer (AOC) subtype.
Time frame: Baseline
Mutational status of HRD and BRCA in high-grade serous advanced ovarian cancer (AOC).
Time frame: Baseline
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 25 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Ovarian Cancer by FIGO Stage
RecruitingPhase 3
Mo-Rez in First- Line (1L) Maintenance Treatment of Non-Homologous Recombination Deficient Ovarian Cancer (Non-HRd OC) [BEHOLD-Ovarian03]
Ovarian Neoplasms
Active, not recruitingPhase 1
Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer
FIGO Stage IVA Ovarian Cancer, FIGO Stage IVB Ovarian Cancer
RecruitingPhase 1
Study of CryptiVax-1001 in Maintenance Setting for Advanced Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Ovarian Cancer, HGSOC
RecruitingPhase 3
Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer
Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube High Grade Serous Adenocarcinoma
Active, not recruitingPhase 1
A Study Combining the Peposertib (M3814) Pill With Standard Chemotherapy in Patients With Ovarian Cancer With an Expansion in High Grade Serous Ovarian Cancer and Low Grade Serous Ovarian Cancer
Endometrial High Grade Endometrioid Adenocarcinoma, Fallopian Tube Clear Cell Adenocarcinoma
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.
Angélica Rodrigues principal investigator
Oncocentro de Minas Gerais
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer by FIGO Stage and Ovarian Cancer Stage III, run by Latin American Cooperative Oncology Group at 17 sites in 4 countries.
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 8 inclusion and 4 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: opening soon, as of the sponsor's last update on 25 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 17 sites in Brazil, Argentina, Mexico, Colombia. 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?
Contact Project Manager (+55 (51) 3384.5334, lacog1325@lacog.group), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of high-grade serous advanced ovarian cancer (AOC) cases overlapping FRα, HER2, PD-L1 positive expression and aberration positives for HRD and BRCA. (time frame: Data is extracted from retrospective medical records covering cases diagnosed from 2018 to 2024, with no prospective clinical follow-up or therapeutic interventions proposed.). 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 25 Aug 2026.