A Study to Evaluate Folate Receptor Alpha (FRα) Expression in Adult Participants With Ovarian, Fallopian Tube, and Primary Peritoneal Cancer in Italy

Folate Receptor Alpha Expression in Relapsed Ovarian, Fallopian Tube and Primary Peritoneal Cancer: a Realworld prEvalence Study in Italy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07407062

Acronym

FORCE

Enrollment

200

Registered

2026-02-12

Start date

2026-06-26

Completion date

2026-11-01

Last updated

2026-07-27

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

Conditions

Cancer - Ovarian

Keywords

Cancer - Ovarian

Brief summary

The purpose of this study is to evaluate the prevalence of folate receptor alpha (FRα)-positive status (≥75% viable tumor cells with moderate (2+) and/or strong (3+) membrane staining) in participants with high-grade serous ovarian, fallopian tube, and primary peritoneal cancer, stratified by time of sampling (initial diagnosis versus relapse), adhering to Ventana folate receptor alpha (FOLR1) RxDx (prescription diagnosis) assay Interpretation Guidance.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Relapsed ovarian, fallopian tube and primary peritoneal cancer * Histologically high-grade serous carcinoma * Presence of archived surgical tissue samples from participants with epithelial ovarian cancer at diagnosis and at 1st recurrence in the same participants * Available samples collected from January 1st, 2016 to study start date (defined as study site initiation visit date) that are considered adequate for the Ventana folate receptor alpha (FOLR1) RxDx assay by the site pathologist

Exclusion criteria

* Histological ambiguous diagnosis upon review * Diagnosis based on cytology and without any biopsy or surgical specimen * Other histotypes than high grade serous ovarian cancer, fallopian tube cancer and primary peritoneal cancer * Archival or recurrent sample for the same participant not available

Design outcomes

Primary

Measure	Time frame	Description
FRα - Positive Status	Up to Approximately 6 Months	FRα - positive status, defined as ≥75% viable tumor cells demonstrating moderate (2+) and/or strong (3+) membrane staining with the Ventana FOLR1 RxDx assay, at diagnosis and/or at relapse.

Countries

Italy

Contacts

CONTACTCaterina Golotta

caterina.golotta@abbvie.com+39 06 548891

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results