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Molecular Ovarian Cancer Assessment in LatiNoAmerican PAtients

NCT07771400 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 320

Last updated 2026-08-18

No results posted yet for this 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.

Conditions

  • 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

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY

  • EVA - Grupo Brasileiro de Tumores Ginecológicos

    collaborator UNKNOWN

  • Latin American Cooperative Oncology Group

    lead OTHER

Principal Investigators

  • Angélica Rodrigues · Oncocentro de Minas Gerais

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-04-30
Completion
2027-08-31

Countries

  • Argentina
  • Brazil
  • Colombia
  • Mexico

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07771400 on ClinicalTrials.gov