VOCAL Study

Primary Objectives

The primary objective of this study is to determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the Venn Ovarian Cancer Liquid Biopsy among women with ovarian adnexal mass for which a surgery is planned. Tumor primary site and malignancy will be confirmed by histopathologic examination.

Secondary Objective

The secondary objective of this study is to evaluate the association of proteins and Glycoproteins (GPs) biomarkers with histological subtypes, stage, treatments and disease free survival (DFS) among ovarian cancer patients.

Sites

This clinical validation study will be performed at approximately 5 sites in US, 15 sites in Malaysia and 3 sites in Philippines.

At Sponsor’s discretion, this study may be expanded to other countries.

Study Population

Women at least 18 years of age, who present ovarian adnexal mass for which a diagnostic procedure or surgery is planned. Subjects are considered enrolled after understanding and signing the ICF and a determination is made by the Investigator or the study coordinator that the subject is eligible to participate according to the inclusion/exclusion criteria and subject has completed the questionnaire. Enrollment will be stopped when a sufficient number of confirmed cases of ovarian cancer have been diagnosed among the study population. Additionally, we will enroll a control group of about 10-15 % of the total study population with newly diagnosed clinically benign adnexal masses for whom no intervention surgery is planned.

Under the current assumptions, up to 600 participants will need to be enrolled from US sites and up to 600 from Malaysia and Philippines.