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Clinical Trials in Italy / NCT06709872
Recruiting Observational

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

NCT06709872 · tracked via the Priya Life Science Italy tracker
Sponsor
KU Leuven
Phase
Observational
Started
2025-06-03
Last updated
2026-05-22

Condition(s) studied

Stage I Ovarian CancerBorderline Ovarian Tumors

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Participants eligible for inclusion in this study must meet all of the following criteria: 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures 2. At least 18 years of age at the time of signing the Informed Consent Form (ICF) 3. Ultrasound discovery of a cyst on the ovary, suspicious for BOT or stage I invasive tumor (subjective assessment) Exclusion Criteria: * Participants eligible for this Study must not meet any of the following criteria: 1. Participants younger than 18 years old, 2. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive 3. Participants who refuse the preoperative transvaginal ultrasonography and/or blood sample 4. Participants with known simultaneous and/or previous malignancies within five years prior to BIOC participation 5. Participants with infectious serology (i.e. HIV, Hepatitis B, Hepatitis C) 6. Participants who deny or withdraw the written informed consent

Primary outcome measure(s)

  • Diagnostic performance of biomarkers — After 12 months following the recruitment
    Diagnostic performance of a protein-based biomarker or set of biomarkers that can discriminate between BOT and stage I invasive ovarian cancer in terms of area under the receiver operative characteristics curve (AUROC).

Trial sites (4)

FacilityCityRegionStatus
UZ Leuven Leuven Flemish Brabant Recruiting
General Faculty Hospital of the Charles University Prague Czechia Recruiting
Istituto Nazionale dei Tumore Milan Italy Not Yet Recruiting
Università Cattolica del Sacro Cuore Rome Italy Not Yet 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 NCT06709872 on ClinicalTrials.gov ↗ ← All trials in Italy