A Study to Evaluate Folate Receptor Alpha (FRα) Expression in Adult Participants With Ovarian, Fallopian Tube, and Primary Peritoneal Cancer in Italy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cancer - Ovarian. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Folate Receptor Alpha Expression in Relapsed Ovarian, Fallopian Tube and Primary Peritoneal Cancer: a Realworld prEvalence Study in Italy
Overview
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.
Primary outcome measures
- FRα - Positive Status [Time frame: Up to Approximately 6 Months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 2802 — Rome
Identifiers
NCT: NCT07407062 · H26-138