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Folate receptor alpha (FRα) expression and heterogeneity in epithelial ovarian cancer

NCT ID NCT07889843

Sponsor: Hellenic Cooperative Oncology Group Source: ClinicalTrials.gov ↗

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Recruiting now This study
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Cancelled before anyone took part.

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First seen Oct 22, 2026 · Last updated Oct 23, 2026 · Updated 1 time

Summary

This is a single-country, retrospective, observational biomarker study conducted in Greece to evaluate Folate Receptor Alpha (FRα) expression in patients with high-grade serous ovarian, fallopian tube, and primary peritoneal cancer at the time of diagnosis. Approximately 200 eligible female patients (≥18 years) diagnosed between 1 January 2001 and 30 July 2025 will be included from around 15 clinical sites affiliated with the Hellenic Cooperative Oncology Group. Historically collected Formalin-Fixed Paraffin-Embedded (FFPE) tissue samples stored in the Hellenic Cooperative Oncology Group biobank will be analyzed centrally using the Ventana FOLR1 RxDx assay to determine FRα expression. Only samples collected at initial diagnosis will be included; relapse samples will be excluded. The primary objective is to assess the prevalence of FRα-positive status, defined as ≥75% viable tumor cells with moderate (2+) and/or strong (3+) membrane staining. Secondary objectives include evaluation of intra-tumoral heterogeneity, concordance between primary and metastatic lesions, prevalence of lower FRα expression levels, and associations between FRα expression and clinical characteristics, BRCA/HRD status, progression-free survival (PFS), and overall survival (OS). All analyses will be descriptive, with additional exploratory statistical methods including chi-square tests, Cohen's kappa, correlation analyses, ANOVA, Kaplan-Meier survival analysis, and Cox proportional hazards models. Data will be retrospectively collected from the Hellenic Cooperative Oncology Group registry and medical records and entered into a secure REDCap eCRF system.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will consist of approximately 200 female patients aged ≥18 years with histologically confirmed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. Tumor tissue samples will be retrospectively collected from the HeCOG biobank and affiliated clinical sites between January 1, 2001 and July 30, 2025. Only samples with adequate tissue quality for immunohistochemical analysis will be included. Cases with non-epithelial ovarian tumors or non-high-grade serous histologies (e.g., endometrioid, mucinous, or clear cell carcinoma) will be excluded.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Female patients. * 18 years of age or older. * Patients diagnosed with high-grade serous epithelial ovarian cancer according to pathologists' report. Exclusion Criteria: * Diagnosis of non-epithelial ovarian tumors * Diagnosis of endometrioid, mucinous, or clear cell carcinomas. * Inadequate (poor quality or inadequate posology for analysis) tissue samples.

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Conditions

The condition(s) this trial relates to.

ovarian cancer ovarian serous adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Folate receptor alpha positive High grade serous ovarian cancer

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Hellenic Cooperative Oncology Group

    RECRUITING

    Athens, Greece

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