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Molecular Ovarian Cancer Assessment in LatiNoAmerican PAtients (MOANA)

24 de agosto de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

320

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Project Manager
  • Número de teléfono: +55 (51) 3384.5334
  • Correo electrónico: lacog1325@lacog.group

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of high-grade serous advanced ovarian cancer (AOC) cases overlapping FRα, HER2, PD-L1 positive expression and aberration positives for HRD and BRCA.
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Socio-demographic and clinicopathologic characteristics of Latin American advanced ovarian cancer (AOC) patients.
Periodo de tiempo: 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).
Periodo de tiempo: 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.
Periodo de tiempo: 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).
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Latin American Cooperative Oncology Group

Colaboradores

AbbVie
EVA - Grupo Brasileiro de Tumores Ginecológicos

Investigadores

  • Investigador principal: Angélica Rodrigues, Oncocentro de Minas Gerais

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de abril de 2027

Finalización del estudio (Estimado)

1 de agosto de 2027

Fechas de registro del estudio

Enviado por primera vez

11 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

14 de agosto de 2026

Publicado por primera vez (Actual)

18 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

24 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • LACOG 1325

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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