A Prospective Multicenter Diagnostic Biomarker Study to Discriminate Borderline From Stage I Invasive Ovarian Cancer
Recruiting now
Conditions studied: Stage I Ovarian Cancer, Borderline Ovarian Tumors
In brief
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.
Key facts
- Study ID
- NCT06709872
- Run by
- KU Leuven
- People needed
- 400
- Starts
- 2025-06-03
- Expected to finish
- 2029-09-03
- Last updated by the study team
- 2026-05-22
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Participants eligible for inclusion in this study must meet all of the following criteria:
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- Ultrasound discovery of a cyst on the ovary, suspicious for BOT or stage I invasive tumor (subjective assessment)
You may not qualify if…
- Participants eligible for this Study must not meet any of the following criteria:
- Participants younger than 18 years old,
- 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
- Participants who refuse the preoperative transvaginal ultrasonography and/or blood sample
- Participants with known simultaneous and/or previous malignancies within five years prior to BIOC participation
- Participants with infectious serology (i.e. HIV, Hepatitis B, Hepatitis C)
- Participants who deny or withdraw the written informed consent
Where it is running
- UZ Leuven — Leuven, Flemish Brabant, Belgium (enrolling)
- General Faculty Hospital of the Charles University — Prague, Czechia (enrolling)
- Istituto Nazionale dei Tumore — Milan, Italy
- Università Cattolica del Sacro Cuore — Rome, Italy
Full record on ClinicalTrials.gov
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