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Molecular Ovarian Cancer Assessment in LatiNoAmerican PAtients (MOANA)

24 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

320

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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).

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of high-grade serous advanced ovarian cancer (AOC) cases overlapping FRα, HER2, PD-L1 positive expression and aberration positives for HRD and BRCA.
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Socio-demographic and clinicopathologic characteristics of Latin American advanced ovarian cancer (AOC) patients.
Délai: 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).
Délai: 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.
Délai: 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).
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Latin American Cooperative Oncology Group

Collaborateurs

AbbVie
EVA - Grupo Brasileiro de Tumores Ginecológicos

Les enquêteurs

  • Chercheur principal: Angélica Rodrigues, Oncocentro de Minas Gerais

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

1 avril 2027

Achèvement de l'étude (Estimé)

1 août 2027

Dates d'inscription aux études

Première soumission

11 août 2026

Première soumission répondant aux critères de contrôle qualité

14 août 2026

Première publication (Réel)

18 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • LACOG 1325

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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