ClinicalTrials.gg
RecruitingNCT07771400MOANAUpdated Nov 13, 2026

Molecular Ovarian Cancer Assessment in LatiNoAmerican PAtients

An observational study in Ovarian Cancer by FIGO Stage, Ovarian Cancer Stage III and Ovarian Cancer Stage IV, sponsored by Latin American Cooperative Oncology Group. Recruiting at 17 sites in 4 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by Latin American Cooperative Oncology Group · Observational

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Updated Nov 13, 2026Now RecruitingSite recruiting status changed+2 moreGo to Updates ↓

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
320
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 44 studies in Ovarian Neoplasms with a site in Brazil — 13 open to participants now, 24 under way, 16 of them phase 3. Ovarian Neoplasms · Brazil.

Started
2026
with 4 others
Observational
6 of 44
2 open now
Primary completion
2027-04
later than 11 of 23 live
Registered
43rd of 44
by date
Lead sponsor
3 of 44
Latin American Cooperative Oncology Group

Among the 44 studies in Ovarian Neoplasms with a site in Brazil, this one is one of 5 that started in 2026, is one of 6 observational ones, reaches primary completion later than 11 of the 23 other live ones, and was the 43rd registered.

Ovarian Neoplasms

3,385 studies on the registry are indexed under Ovarian Neoplasms; 792 are open to participants now.

Browse Ovarian Neoplasms studies →

Open to participants now

13 of the 44 studies in Ovarian Neoplasms with a site in Brazil are open now. Recruiting first, the newest first:

7 more — sign in →

All 13 open studies →

A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →

Who these studies take

Of the 605 Ovarian Neoplasms studies recruiting now, 442 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 44 studies in Ovarian Neoplasms with a site in Brazil, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participants ≥18 years-old.
  2. Patients diagnosed with ovarian, fallopian tube or peritoneal cancer:

    1. advanced stages stage III or IV by FIGO disease stage
    2. new diagnosis and persistent or recurrent disease
  3. Diagnosed from 2018 to 2024.
  4. confirmed diagnosis of serous (low or high grade), endometrioid, mucinous or clear cell ovarian carcinoma.
  5. Accept to participate in the project and sign the (if applicable).
  6. An archived representative formalin-fixed paraffin-embedded (FFPE) tumor specimen in tumor tissue blocks (preferred) or freshly sectioned unstained slides (at least 20) from /surgery is mandatory.

Exclusion criteria

Exclusion Criteria:

  1. Histological ambiguous diagnosis upon review.
  2. Diagnosis based on cytology and without any or surgical specimen.
  3. Patients diagnosed and staged but not receiving any treatment.
  4. Patients without medical records available (lost, empty or irretrievable clinical information).
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
320 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

  3. 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%.

    Time frame: Baseline

  4. 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.

    Time frame: Baseline

07

Study locations

5 of 17 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2026 (actual). Primary completion is estimated for Apr 2027, 7 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2026
First posted
Aug 18, 2026
StartActual
Sep 8, 2026
Primary completionEst.
Apr 2027
CompletionEst.
Aug 2027
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Nov 13, 2026
Sites
1 site added, 1 site removed. 16 sites changed recruiting status (12 now not yet recruiting, 4 now recruiting)
Show 16 sites
  • Hospital Alemán de Buenos Aires · Buenos Aires, Argentinano status→Not yet recruiting
  • Instituto Alexander Fleming · Buenos Aires, Argentinano status→Not yet recruiting
  • Fundación Pita · Rosario, Argentinano status→Not yet recruiting
  • Oncocentro de Minas Gerais · Belo Horizonte, Brazilno status→Recruiting
  • IMIP - Instituto de Medicina Integral Professor Fernando Figueira · Recife, Brazilno status→Not yet recruiting
  • CTTB - Centro de Tratamento de Tumores Botafogo (Oncoclínicas) · Rio de Janeiro, Brazilno status→Recruiting
  • Liga Norte Riograndense Contra o Câncer · Natal, Brazilno status→Recruiting
  • Futtura Oncologia Hub de Pesquisa Clinica Ltda · Porto Alegre, Brazilno status→Recruiting
  • ANIMI - Unidade de Tratamento Oncológico · Lages, Brazilno status→Not yet recruiting
  • Fundação Antonio Prudente - A.C. Camargo Cancer Center · São Paulo, Brazilno status→Not yet recruiting
  • HIAE - Hospital Israelita Albert Einstein · São Paulo, Brazilno status→Not yet recruiting
  • Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer · Bogotá, Colombiano status→Not yet recruiting
  • Instituto Nacional de Cancerología Colombia · Bogotá, Colombiano status→Not yet recruiting
  • Hospital Ángeles Pedregal · Mexico City, Mexicono status→Not yet recruiting
  • INCan - Instituto Nacional de Cancerología · Mexico City, Mexicono status→Not yet recruiting
  • TecSalud (Tecnológico de Monterrey) · Nuevo León, Mexicono status→Not yet recruiting
Show site
  • Clínica Prognóstica - Centro de Pesquisa Clínica Onconeo · Campo Grande, Brazil
Show 1 removed
  • Clínica Prognóstica - Centro de Pesquisa Clínica Onconeo · Campo Grande, Brazil
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    Not yet recruiting→Recruiting
    1 site added, 1 site removed. 16 sites changed recruiting status (12 now not yet recruiting, 4 now recruiting)
    Show 16 sites
    • Hospital Alemán de Buenos Aires · Buenos Aires, Argentinano status→Not yet recruiting
    • Instituto Alexander Fleming · Buenos Aires, Argentinano status→Not yet recruiting
    • Fundación Pita · Rosario, Argentinano status→Not yet recruiting
    • Oncocentro de Minas Gerais · Belo Horizonte, Brazilno status→Recruiting
    • IMIP - Instituto de Medicina Integral Professor Fernando Figueira · Recife, Brazilno status→Not yet recruiting
    • CTTB - Centro de Tratamento de Tumores Botafogo (Oncoclínicas) · Rio de Janeiro, Brazilno status→Recruiting
    • Liga Norte Riograndense Contra o Câncer · Natal, Brazilno status→Recruiting
    • Futtura Oncologia Hub de Pesquisa Clinica Ltda · Porto Alegre, Brazilno status→Recruiting
    • ANIMI - Unidade de Tratamento Oncológico · Lages, Brazilno status→Not yet recruiting
    • Fundação Antonio Prudente - A.C. Camargo Cancer Center · São Paulo, Brazilno status→Not yet recruiting
    • HIAE - Hospital Israelita Albert Einstein · São Paulo, Brazilno status→Not yet recruiting
    • Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer · Bogotá, Colombiano status→Not yet recruiting
    • Instituto Nacional de Cancerología Colombia · Bogotá, Colombiano status→Not yet recruiting
    • Hospital Ángeles Pedregal · Mexico City, Mexicono status→Not yet recruiting
    • INCan - Instituto Nacional de Cancerología · Mexico City, Mexicono status→Not yet recruiting
    • TecSalud (Tecnológico de Monterrey) · Nuevo León, Mexicono status→Not yet recruiting
    Show site
    • Clínica Prognóstica - Centro de Pesquisa Clínica Onconeo · Campo Grande, Brazil
    Show 1 removed
    • Clínica Prognóstica - Centro de Pesquisa Clínica Onconeo · Campo Grande, Brazil
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07771400
Lead sponsor
Latin American Cooperative Oncology Group
Collaborators
AbbVie, EVA - Grupo Brasileiro de Tumores Ginecológicos
Responsible party
Sponsor
First posted
Aug 18, 2026
Start date
Sep 8, 2026
Primary completion
Apr 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Nov 13, 2026

Study contacts

Project Manager
Contact
lacog1325@lacog.group
+55 (51) 3384.5334
Laura Voelcker
Contact
laura.voelcker@lacog.group
+55 (51) 3384.5334
Angélica Rodrigues
principal investigator · Oncocentro de Minas Gerais

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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