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

Study Identifier
H26-138
CT.gov Identifier
NCT07407062
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Study Details

Medical Condition
  • Ovarian Cancer
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female
    Age
    18+ years
    Inclusion and 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

    Protocol 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.

    Study Locations

    No locations found.