Evaluation of Multiple Protein and Molecular Biomarkers to Estimate Risk of Cancer in Gynecology Patients Presenting With a Pelvic Mass.

ANGLE has developed the Parsortix™ Cell Separation System (Parsortix), an automated system capable of harvesting rare circulating cells for analysis from a sample of peripheral blood based on cellular size and deformability. In a small pilot study, scientists at the Medical University of Vienna demonstrated that measurement of a combination of mRNA markers extracted from CTCs captured using the Parsortix system could be used to identify women with ovarian cancer. This study is designed to provide specimens for optimization of an assay using clinical and biomarker information (i.e. demographics, imaging results and/or serum tumor markers) in combination with mRNA extracted from rare cells in the blood of women presenting with a pelvic mass for the detection of malignancy. Primary Objective: Optimization of an assay/algorithm for the differentiation of women with benign pelvic masses from those with malignant pelvic masses using clinical and biomarker information (i.e. demographics, imaging results and/or serum tumor markers) in combination with mRNA markers extracted from rare cells isolated from whole blood. Multiple serum protein markers and mRNA markers will be measured, and the results will be compared to the actual clinical diagnosis made for each subject through other recognized methods (i.e. histopathology). Statistical modeling will be used to combine the clinical information, serum protein markers and/or mRNA markers for estimation of the risk of malignancy. If successful, the resulting risk algorithm will be evaluated in future, appropriately powered, prospective studies. Exploratory Objective: Use statistical modeling to determine the need for and/or preliminary design of a mathematical algorithm to combine the clinical information, serum protein markers and/or mRNA markers for estimation of the risk of malignancy.