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Clinical Trials in Mexico / NCT07539844
Recruiting Observational

Study to Assess Prevalence of the Folate Receptor Alpha (FRa) in Adult Female Participants With Ovarian Cancer in Intercontinental (InterCon) Countries

NCT07539844 · tracked via the Priya Life Science Mexico tracker
Sponsor
AbbVie
Phase
Observational
Started
2026-07-02
Last updated
2026-09-14

Condition(s) studied

Ovarian Cancer

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Folate Receptor Alpha (FRa) Overexpression Immunohistochemistry (IHC)in Each Participating Sites (Local and Central) — Up to Approximately 1 Year
    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.

Trial sites (12)

FacilityCityRegionStatus
Biomakers /ID# 280318 Buenos Aires Buenos Aires Recruiting
Hospital Italiano de Buenos Aires /ID# 280315 Buenos Aires Buenos Aires Recruiting
Instituto Alexander Fleming /ID# 281479 Ciudad Autonoma de Buenos Aire Buenos Aires F.D. Recruiting
A.C. Camargo Cancer Center - Rua Professor Antonio Prudente /ID# 280407 São Paulo São Paulo Recruiting
Brazil - Generic Institution /ID# 287000 São Paulo Brazil Recruiting
Toronto General Hospital-University Health Network /ID# 282521 Toronto Ontario Recruiting
Fundacion Para La Investigacion Clinica Y Molecular Aplicada Del Cancer - Ficmac /ID# 282327 Bogotá Bogota D.C. Recruiting
Instituto Nacional De Cancerologia /ID# 282312 Bogota Cundinamarca Recruiting
Fundacion Valle Del Lili /ID# 280794 Cali Valle del Cauca Department Recruiting
Mexico - Generic Institution /ID# 281927 Mexico City Mexico Recruiting
Mexico - Generic Institution /ID# 281928 Mexico City Mexico Recruiting
Mexico - Generic Institution /ID# 281930 Mexico City Mexico Recruiting

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Other trials for the same condition

Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery Active, not recruiting
HIPEC in Ovarian Carcinoma Clinical Stage IIIC and IV During Interval Laparotomy Recruiting
Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65). Active, not recruiting
A Trial of Vigil for Participants With Ovarian Cancer Active, not recruiting
A Study of Avutometinib (VS-6766) v. Avutometinib (VS-6766) + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer With and Without a KRAS Mutation Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07539844 on ClinicalTrials.gov ↗ ← All trials in Mexico