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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07539844

Acronym

ConFeR

Enrollment

1000

Registered

2026-04-20

Start date

2026-07-02

Completion date

2027-03-01

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer, Elahere

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Argentina, Brazil, Canada, Colombia, Mexico

Contacts

CONTACTRebekah Taylor

rebekah.taylor@abbvie.com(847) 937-8000

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results