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Clinical Trials in Brazil / NCT07771400
Starting soon Observational

Molecular Ovarian Cancer Assessment in LatiNoAmerican PAtients

NCT07771400 · tracked via the Priya Life Science Brazil tracker
Sponsor
Latin American Cooperative Oncology Group
Phase
Observational
Started
2026-09
Last updated
2026-08-25

Condition(s) studied

Ovarian Cancer by FIGO StageOvarian Cancer Stage IIIOvarian Cancer Stage IVFallopian Tube Cancer Stage IIIFallopian Tube Cancer Stage IVFallopian Tube Cancers

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Percentage of high-grade serous advanced ovarian cancer (AOC) cases overlapping FRα, HER2, PD-L1 positive expression and aberration positives for HRD and BRCA. — 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.

Trial sites (17)

FacilityCityRegionStatus
Hospital Alemán de Buenos Aires Buenos Aires Argentina
Instituto Alexander Fleming Buenos Aires Argentina
Fundación Pita Rosario Argentina
Clínica Prognóstica - Centro de Pesquisa Clínica Onconeo Campo Grande Mato Grosso do Sul
Oncocentro de Minas Gerais Belo Horizonte Minas Gerais
IMIP - Instituto de Medicina Integral Professor Fernando Figueira Recife Pernambuco
CTTB - Centro de Tratamento de Tumores Botafogo (Oncoclínicas) Rio de Janeiro Rio de Janeiro
Liga Norte Riograndense Contra o Câncer Natal Rio Grande do Norte
Futtura Oncologia Hub de Pesquisa Clinica Ltda Porto Alegre Rio Grande do Sul
ANIMI - Unidade de Tratamento Oncológico Lages Santa Catarina
Fundação Antonio Prudente - A.C. Camargo Cancer Center São Paulo São Paulo
HIAE - Hospital Israelita Albert Einstein São Paulo São Paulo
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Bogotá Colombia
Instituto Nacional de Cancerología Colombia Bogotá Colombia
Hospital Ángeles Pedregal Mexico City Mexico
INCan - Instituto Nacional de Cancerología Mexico City Mexico
TecSalud (Tecnológico de Monterrey) Nuevo León Mexico

More Latin American Cooperative Oncology Group trials in Brazil

Neuroendocrine Carcinomas: Patient Journey And Treatment Outcomes In Latin America Recruiting
A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cancer) Recruiting
Sac-TMT in Vaginal and Vulvar Cancers Starting soon
Classifying for HER2 Dependence to De-Escalate Neoadjuvant Chemotherapy in Patients With HER2+ Early Breast Cancer Undergoing HER2 Double-Blockade Active, not recruiting
Validation of the G8 Screening Tool for Prognostic Assessment of Frailty and Early Mortality in Elderly Individuals With Cancer: Prospective Cohort Study in Brazil Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07771400 on ClinicalTrials.gov ↗ ← All trials in Brazil