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Molecular Ovarian Cancer Assessment in LatiNoAmerican PAtients (MOANA)

24 augustus 2026 bijgewerkt door: Latin American Cooperative Oncology Group

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

320

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Argentinië
      • Buenos Aires, Argentinië
      • Buenos Aires, Argentinië
      • Rosario, Argentinië
  • Brazilië
    • Mato Grosso do Sul
      • Campo Grande, Mato Grosso do Sul, Brazilië, 79002-061
        • Clínica Prognóstica - Centro de Pesquisa Clínica Onconeo
        • Contact:
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazilië, 30360-680
        • Oncocentro de Minas Gerais
        • Contact:
    • Pernambuco
      • Recife, Pernambuco, Brazilië, 50070-902
        • IMIP - Instituto de Medicina Integral Professor Fernando Figueira
        • Contact:
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazilië, 59062-000
        • Liga Norte Riograndense Contra O Cancer
        • Contact:
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazilië, 90470-340
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazilië, 22250-905
    • Santa Catarina
      • Lages, Santa Catarina, Brazilië, 88501-001
        • ANIMI - Unidade de Tratamento Oncologico
        • Contact:
    • São Paulo
      • São Paulo, São Paulo, Brazilië, 01509-001
      • São Paulo, São Paulo, Brazilië, 05653-000
        • HIAE - Hospital Israelita Albert Einstein
        • Contact:
  • Colombia
      • Bogotá, Colombia
        • Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer
        • Contact:
      • Bogotá, Colombia
        • Instituto Nacional de Cancerología Colombia
        • Contact:
  • Mexico
      • Mexico City, Mexico
      • Mexico City, Mexico
        • INCan - Instituto Nacional de Cancerología
        • Contact:
      • Nuevo León, Mexico

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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. Histologically 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 informed consent (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 biopsy/surgery is mandatory.

Exclusion Criteria:

  1. Histological ambiguous diagnosis upon review.
  2. Diagnosis based on cytology and without any biopsy 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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of high-grade serous advanced ovarian cancer (AOC) cases overlapping FRα, HER2, PD-L1 positive expression and aberration positives for HRD and BRCA.
Tijdsspanne: 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.
Data is extracted from retrospective medical records covering cases diagnosed from 2018 to 2024, with no prospective clinical follow-up or therapeutic interventions proposed.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Socio-demographic and clinicopathologic characteristics of Latin American advanced ovarian cancer (AOC) patients.
Tijdsspanne: Baseline
Description and summarization of socio-demographic and clinicopathologic characteristics (including histological subtypes) of the study population, presented as frequencies and percentages.
Baseline
Treatment patterns of high-grade serous advanced ovarian cancer (AOC).
Tijdsspanne: Baseline
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.
Baseline
Folate receptor alpha (FRα), HER2, and PD-L1 expression by histologic advanced ovarian cancer (AOC) subtype.
Tijdsspanne: Baseline
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%.
Baseline
Mutational status of HRD and BRCA in high-grade serous advanced ovarian cancer (AOC).
Tijdsspanne: Baseline
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.
Baseline

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Latin American Cooperative Oncology Group

Medewerkers

AbbVie
EVA - Grupo Brasileiro de Tumores Ginecológicos

Onderzoekers

  • Hoofdonderzoeker: Angélica Rodrigues, Oncocentro de Minas Gerais

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 april 2027

Studie voltooiing (Geschat)

1 augustus 2027

Studieregistratiedata

Eerst ingediend

11 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

14 augustus 2026

Eerst geplaatst (Werkelijk)

18 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

24 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • LACOG 1325

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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