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RECRUITING
NCT06709872

A Prospective Multicenter Diagnostic Biomarker Study to Discriminate Borderline From Stage I Invasive Ovarian Cancer

Sponsor: KU Leuven

View on ClinicalTrials.gov

Summary

The study aims to improve the diagnosis of ovarian cancer by distinguishing between borderline ovarian tumors (BOT) and stage I invasive ovarian cancer. Other than the traditional diagnostic biomarker CA125, the previous study TRANS-IOTA (translational-international ovarian tumor analysis; S51375/S59207), conducted by similar investigators, pointed at biomarkers like HE4, CA72.4, CA15.3, and CCL11, as potential markers to discriminate BOT from stage I cancer. BIOC is the follow-up study, which will include four additional promising biomarkers to expand the panel to nine. The investigators aim to confirm whether a subpanel of these nine biomarkers has diagnostic value. Such a biomarker signature would enhance the accuracy of distinguishing between BOT and stage I invasive ovarian cancer before surgery, leading to more precise treatment and improved patient outcomes.

Official title: Discriminating Borderline From Stage I Invasive Ovarian Cancer (BIOC): a Prospective Multicenter Diagnostic Biomarker Study

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2025-06-03

Completion Date

2029-09-03

Last Updated

2026-05-22

Healthy Volunteers

No

Locations (4)

UZ Leuven

Leuven, Flemish Brabant, Belgium

General Faculty Hospital of the Charles University

Prague, Czechia

Istituto Nazionale dei Tumore

Milan, Italy

Università Cattolica del Sacro Cuore

Rome, Italy