NCT07539844

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
3 countries

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Jul 2026Mar 2027

First Submitted

Initial submission to the registry

April 14, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 2, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

8 months

First QC Date

April 14, 2026

Last Update Submit

July 30, 2026

Conditions

Ovarian Cancer

Keywords

Ovarian CancerElahere

Outcome Measures

Primary Outcomes (1)

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

    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.

    Up to Approximately 1 Year

Study Arms (1)

Banked Tissue Samples Undergoing Chart Review

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population is surgical or biopsy sample from an adult female with tumoral High Grade Serous Ovarian Cancer.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Instituto Alexander Fleming /ID# 281479

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1426, Argentina

RECRUITING

Biomakers /ID# 280318

Buenos Aires, 1119, Argentina

RECRUITING

Hospital Italiano de Buenos Aires /ID# 280315

Buenos Aires, 1181, Argentina

RECRUITING

A.C. Camargo Cancer Center - Rua Professor Antonio Prudente /ID# 280407

São Paulo, 01509-900, Brazil

RECRUITING

Fundacion Para La Investigacion Clinica Y Molecular Aplicada Del Cancer - Ficmac /ID# 282327

Bogotá, Bogota D.C., 110111, Colombia

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Central Study Contacts

Rebekah Taylor

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2026

First Posted

April 20, 2026

Study Start

July 2, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

July 31, 2026

Record last verified: 2026-07

Locations

AR(3)BR(1)CO(1)