Recruiting

Observational Study

Sponsor:

AbbVie

Code:

NCT07539844

Conditions

Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Ovarian Cancer

Study ID

NCT07539844

Start date

Jul 2, 2026

Status verified date

Sep, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Banked Tissue Samples Undergoing Chart Review

Banked tissue samples undergoing chart review and retrospective folate receptor alpha (FRa) testing of tissue biopsies.

Primary outcome measure

  • Folate Receptor Alpha (FRa) Overexpression Immunohistochemistry (IHC)in Each Participating Sites (Local and Central) [ Time Frame: Up to Approximately 1 Year ]

Central Contacts and Locations

Central contacts

Rebekah Taylor

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

Locations

Toronto General Hospital-University Health Network /ID# 282521

Recruiting

Toronto, Ontario, Canada, M5G 2C4

More Information

Sponsor

AbbVie

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Keywords

  • Ovarian Cancer
  • Elahere

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by AbbVie on 2026-09-14.