Clinical Protocol to Evaluate Glycans Analysis As a Diagnostic Test for Ovarian Cancer
- Evaluate the accuracy of glycan analysis to distinguish between normal healthy control
female subjects and those with ovarian epithelial cancer.
- Compare the new assay to the standard CA 125 for diagnostic accuracy.
- Ovarian cancer patients: Blood samples are obtained periodically for up to 2 years.
Patients undergoing surgery have blood samples drawn before and after surgery. Medical
charts are reviewed periodically for up to 3 years.
- Healthy volunteers: One blood sample is obtained. Volunteers also complete a 1-page
PROJECTED ACCRUAL: A total of 300 healthy female participants and 400 patients will be
accrued for this study.
Observational Model: Case Control, Time Perspective: Prospective
Accuracy of glycan analysis
For healthy controls, a single sample will be obtained. For patients scheduled for surgery, two samples will be obtained: one preoperatively and one postoperatively. Ovarian cancer patients who agree to participate in the longitudinal study will have follow-up serum samples drawn periodically during chemotherapy treatments and then during surveillance visits, to correspond with routine blood testing for CA 125. They will be asked to participate for 2 years, with a maximum of 8 blood draws per year (to be coordinated with other venipunctures, if possible).
one time for healthy volunteers; up to 2 years for patients with cancer
Gary Leiserowitz, MD
University of California, Davis
United States: Institutional Review Board
|University of California Davis Cancer Center||Sacramento, California 95817|