FRα Status in High-Grade Serous Ovarian/Peritoneal Cancer
Official title: Folate Receptor Alpha Expression in Relapsed Ovarian, Fallopian Tube and Primary Peritoneal Cancer: a Realworld prEvalence Study in Italy
Run by AbbVie · NCT07407062 · Data updated 2026-11-12
This study tests whether tumors from adults with relapsed or newly diagnosed high-grade serous ovarian, fallopian tube, or primary peritoneal cancer show FRα positivity using a standardized staining method.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 1 site (Rome, Roma) |
| Status | Recruiting |
| Started | June 26, 2026 |
| Main results expected | November 2026 |
| Study ends | November 2026 |
| Registry record updated | July 27, 2026 |
| Trial ID | NCT07407062 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with relapsed or initial high-grade serous ovarian, fallopian tube, or primary peritoneal cancer who have archived tumor tissue from diagnosis and first recurrence suitable for FRα testing.
✕Probably not a fit
Patients without FRα-positive tumors or without suitable archival tissue may not benefit from this testing.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will measure how commonly folate receptor alpha is present in tumor cells from archived tissue samples collected at diagnosis and at first recurrence. Participants are female adults with high-grade serous histology who have archived tissue available and meet other criteria. The study uses the Ventana FOLR1 RxDx assay interpretation guidelines to determine FRα status. No interventions are performed beyond tissue analysis, and sites assess samples for eligibility and adequacy. Results may help clarify how FRα expression relates to disease timing (initial diagnosis vs relapse).
Why it matters
Potential benefit: If FRα positivity is common, it could guide future targeted therapies for this cancer.
How similar studies have gone: Similar FRα expression studies have used standardized assays to characterize receptor prevalence in ovarian cancer, though this exact time-point stratification is less common.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 280205
Rome, Roma, Italy Recruiting
Study contacts
- Study coordinator: Caterina Golotta
- Email: caterina.golotta@abbvie.com
- Phone: +39 06 548891
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.