Glycan Analysis in Diagnosing Cancer in Women With Ovarian Epithelial Cancer and in Healthy Female Participants

Clinical Protocol to Evaluate Glycans Analysis As a Diagnostic Test for Ovarian Cancer

RATIONALE: New diagnostic procedures, such as glycan analysis, may be effective in finding ovarian epithelial cancer.

PURPOSE: This clinical trial is studying how well glycan analysis works in diagnosing cancer in women with ovarian epithelial cancer and in healthy female participants.

OBJECTIVES:

Primary

• Evaluate the accuracy of glycan analysis to distinguish between normal healthy control female subjects and those with ovarian epithelial cancer.

Secondary

• Compare the new assay to the standard CA 125 for diagnostic accuracy.

OUTLINE:

• 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 questionnaire.

PROJECTED ACCRUAL: A total of 300 healthy female participants and 400 patients will be accrued for this study.

Inclusion Criteria:

• Able to understand consent document for participation in the study
• Not pregnant
• Negative pregnancy test

Participants must meet 1 of the following criteria:

• Patients scheduled for ovarian surgery for an ovarian mass
• Healthy female volunteers with no active cancer or history of cancer