The DISARM Clinical Study B (CSB) is a multisite, multi-country, non-commercial, minimal risk, exploratory research study with a case-control design. The study aims to evaluate the discriminatory abilities of innovative liquid biopsy biomarker assays for ovarian cancer, including glycans/glycoproteins (OVA-GLY), volatile organic compounds (OVA-VOC), and circulating miRNAs (OVA-miRNAs). Primary endpoints are the area under the receiver operating characteristic curve (AUC), sensitivity, and specificity of the investigational biomarker assays.
Women with epithelial ovarian cancer (EOC) before treatment and healthy controls (participants without cancer diagnosis) will be recruited across participating European clinical sites. Subjects presenting with adnexal masses suspicious of ovarian cancer will be enrolled and tested before surgery and retrospectively classified according to histopathological findings. No randomisation, blinding, or interventional procedures are foreseen. The only study-specific procedure is the minimally invasive collection of blood samples.
