Study to Assess Prevalence of the Folate Receptor Alpha (FRa) in Adult Female Participants With Ovarian Cancer in Intercontinental (InterCon) Countries
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: Ovarian Cancer. 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
- Argentina, Brazil, Colombia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Concordance Study of Folate Receptor Alpha (FRa) Testing in InterCon Countries
Overview
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.
Primary outcome measures
- Folate Receptor Alpha (FRa) Overexpression Immunohistochemistry (IHC)in Each Participating Sites (Local and Central) [Time frame: Up to Approximately 1 Year]
Eligibility criteria
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
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
- Cohort
Study locations
Argentina · 3 centers
- Instituto Alexander Fleming /ID# 281479 — Ciudad Autonoma de Buenos Aire
- Biomakers /ID# 280318 — Buenos Aires
- Hospital Italiano de Buenos Aires /ID# 280315 — Buenos Aires
Brazil · 1 center
- A.C. Camargo Cancer Center - Rua Professor Antonio Prudente /ID# 280407 — São Paulo
Colombia · 1 center
- Fundacion Para La Investigacion Clinica Y Molecular Aplicada Del Cancer - Ficmac /ID# 2823 — Bogotá
Identifiers
NCT: NCT07539844 · H26-087