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