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

NCT07407062 | Recruiting

• 1 other identifier: H26-138
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer - Ovarian

Keywords

Cancer - Ovarian

Outcome Measures

Primary Outcomes (1)

• FRα - Positive Status

  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.

  Up to Approximately 6 Months

Study Arms (1)

Folate Receptor Alpha (FRα)

Samples of eligible participants with ovarian cancer will be analyzed retrospectively for folate receptor alpha (FRα) expression.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be performed on archived tissue samples from approximately 200 eligible female adult participants with relapsed high grade serous epithelial ovarian cancer.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 280205

Rome, Roma, 00168, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Archived surgical tissue

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

Caterina Golotta

CONTACT

+39 06 548891; caterina.golotta@abbvie.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 12, 2026
• Study Start: June 26, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-07

Locations

IT (1)