Evaluation of Multiple Biomarkers to Estimate Risk of Ovarian Cancer in Patients With a Pelvic Mass.

Within 60 days prior to the pelvic mass evaluation procedure, each subject must have a pelvic imaging study (e.g. ultrasound, CT scan, MRI, etc.) conducted and read to visualize the pelvic mass according to the current standard of care. Results of the pelvic imaging study(ies) will be recorded.

Within 60 days prior to, or on the day of the pelvic mass surgery, collect up to 35mL of whole blood into one 5mL SST tube, which must be drawn first, followed by three separate 10mL EDTA tubes.

A laparotomy or laparoscopic procedure will be performed by a qualified individual for excision of the pelvic mass. Representative tissue samples will be taken from the excised pelvic mass and evaluated in pathology departments within each institution according to institutional guidelines. Results from the histopathological evaluation will be recorded, including the final diagnosis along with histological sub-type, and if available, stage and grade of cancer where disease is identified.