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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorAbbVie

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

200 Participants
are grouped into 1 trial group

Locations

This trial has no locations

Sponsors and collaborators