DISARM Clinical Study B: Evaluation of Innovative Ovarian Cancer Biomarker Assays

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.

Inclusion criteria

EOC patients

• Women, trans men and non-binary people with female reproductive organs
• Aged ≥35 years*
• Pathologically diagnosed, by biopsy, with EOC prior to surgical intervention or treatment
• Presenting with adnexal mass suspicious of OC on imaging and scheduled for surgical resection or biopsy (and subsequent confirmation of EOC)
• Able to give informed consent

Healthy controls

• Women, trans men and non-binary people with female reproductive organs
• Aged ≥35 years
• No cancer history
• Able to give informed consent

Exclusion criteria

• Prior history and any treatment for malignancy
• Prior removal of either ovary for any reason
• Pregnant or lactating
• Any condition or circumstance that, in the opinion of the investigator, could interfere with the participant's ability to participate or comply with study requirements