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

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Instituto Alexander Fleming /ID# 281479, Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Folate Receptor Alpha (FRa) Overexpression Immunohistochemistry (IHC)in Each Participating Sites (Local and Central)

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rebekah Taylor

CONTACT

[email protected]

(847) 937-8000

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Concordance Study of Folate Receptor Alpha (FRa) Testing in InterCon Countries

Acronym: ConFeR

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Apr 20, 2026
Registry last updated: Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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