A Study to Evaluate Folate Receptor Alpha (FRα) Expression in Adult Participants With Ovarian, Fallopian Tube, and Primary Peritoneal Cancer in Italy
Recruiting now
Conditions studied: Cancer - Ovarian
In brief
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.
Key facts
- Study ID
- NCT07407062
- Run by
- AbbVie
- People needed
- 200
- Starts
- 2026-06-26
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2026-07-27
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
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
Where it is running
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 280205 — Rome, Roma, Italy (enrolling)
Full record on ClinicalTrials.gov
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