Study to Assess Prevalence of the Folate Receptor Alpha (FRa) in Adult Female Participants With Ovarian Cancer in Intercontinental (InterCon) Countries

NCT07539844 · tracked via the Priya Life Science Brazil tracker

Sponsor

AbbVie

Phase

Observational

Started

2026-07-02

Last updated

2026-09-14

Condition(s) studied

Ovarian Cancer

Study summary

Epithelial ovarian cancer (OC), including fallopian tube and primary peritoneal cancer, is the deadliest gynecologic malignant neoplasm with a 5-year relative survival of approximately 50%. This study will evaluate the concordance in folate receptor alpha (FRa) immunohistochemistry (IHC) in adult female participants with ovarian cancer.

Archived tissue biopsies will be tested for FRa and data from approximately 1,000 participants will be collected. This is a retrospective study and testing will be performed prospectively on archived samples.

Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the study will be approximately 1 Year.

There is no additional burden for participants in this trial.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Surgical or biopsy samples (Formalin Fixed Paraffin Embedded \[FFPE\]) with tumoral High Grade Serous Ovarian Cancer (HGSOC) material allowing the sectioning of serial slides for all the analyses. * Archival specimens should not be older than 5 years in order to control quality of the samples. * Specimens containing a minimum of 100 viable tumor cells. Exclusion Criteria: * Surgical or biopsy samples (FFPE) with insufficient quantity or quality (sampled more than 5 years ago and/or with less 100 viable tumor cells per section). * Tissue obtained following treatment with Mirvetuximab soravtansine or any other FRa targeted therapy. * Tissue obtained through fine needle aspirations or liquid specimens, or ascites

Primary outcome measure(s)

Folate Receptor Alpha (FRa) Overexpression Immunohistochemistry (IHC)in Each Participating Sites (Local and Central) — Up to Approximately 1 Year
FRa positive overexpression is defined as: tumor cell membrane staining of at least 75% with a 2+ and/or 3+ staining, or FRa negative as: tumor cell membrane staining of less than 75% with a 2+ and/or 3+ staining.

Trial sites (12)

Facility	City	Region	Status
Biomakers /ID# 280318	Buenos Aires	Buenos Aires	Recruiting
Hospital Italiano de Buenos Aires /ID# 280315	Buenos Aires	Buenos Aires	Recruiting
Instituto Alexander Fleming /ID# 281479	Ciudad Autonoma de Buenos Aire	Buenos Aires F.D.	Recruiting
A.C. Camargo Cancer Center - Rua Professor Antonio Prudente /ID# 280407	São Paulo	São Paulo	Recruiting
Brazil - Generic Institution /ID# 287000	São Paulo	Brazil	Recruiting
Toronto General Hospital-University Health Network /ID# 282521	Toronto	Ontario	Recruiting
Fundacion Para La Investigacion Clinica Y Molecular Aplicada Del Cancer - Ficmac /ID# 282327	Bogotá	Bogota D.C.	Recruiting
Instituto Nacional De Cancerologia /ID# 282312	Bogota	Cundinamarca	Recruiting
Fundacion Valle Del Lili /ID# 280794	Cali	Valle del Cauca Department	Recruiting
Mexico - Generic Institution /ID# 281927	Mexico City	Mexico	Recruiting
Mexico - Generic Institution /ID# 281928	Mexico City	Mexico	Recruiting
Mexico - Generic Institution /ID# 281930	Mexico City	Mexico	Recruiting

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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 NCT07539844 on ClinicalTrials.gov ↗ ← All trials in Brazil