Clinical trial · Observational
Study to Assess Prevalence of the Folate Receptor Alpha (FRa) in Adult Female Participants With Ovarian Cancer in Intercontinental (InterCon) Countries
A Concordance Study of Folate Receptor Alpha (FRa) Testing in InterCon Countries
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
Epithelial ovarian cancer (OC), including fallopian tube and primary peritoneal cancer, is the deadliest gynecologic malignant neoplasm with a 5-year relative survival of approximately 50%. This study will evaluate the concordance in folate receptor alpha (FRa) immunohistochemistry (IHC) in adult female participants with ovarian cancer. Archived tissue biopsies will be tested for FRa and data from approximately 1,000 participants will be collected. This is a retrospective study and testing will be performed prospectively on archived samples. Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the study will be approximately 1 Year. There is no additional burden for participants in this trial.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Banked Tissue Samples Undergoing Chart Review
- description
- Banked tissue samples undergoing chart review and retrospective folate receptor alpha (FRa) testing of tissue biopsies.
Primary outcomes (1)
- measure
- Folate Receptor Alpha (FRa) Overexpression Immunohistochemistry (IHC)in Each Participating Sites (Local and Central)
- timeFrame
- Up to Approximately 1 Year
- description
- FRa positive overexpression is defined as: tumor cell membrane staining of at least 75% with a 2+ and/or 3+ staining, or FRa negative as: tumor cell membrane staining of less than 75% with a 2+ and/or 3+ staining.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Surgical or biopsy samples (Formalin Fixed Paraffin Embedded \[FFPE\]) with tumoral High Grade Serous Ovarian Cancer (HGSOC) material allowing the sectioning of serial slides for all the analyses. * Archival specimens should not be older than 5 years in order to control quality of the samples. * Specimens containing a minimum of 100 viable tumor cells. Exclusion Criteria: * Surgical or biopsy samples (FFPE) with insufficient quantity or quality (sampled more than 5 years ago and/or with less 100 viable tumor cells per section). * Tissue obtained following treatment with Mirvetuximab soravtansine or any other FRa targeted therapy. * Tissue obtained through fine needle aspirations or liquid specimens, or ascites
References
Publications (0)
Data not yet available