Spots Global Cancer Trial Database for Glycan Analysis in Diagnosing Cancer in Women With Ovarian Epithelial Cancer and in Healthy Female Participants

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Trial Identification

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

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

Study ID: NCT00628654

Conditions

Ovarian Cancer

Interventions

Study Description

Brief Summary: 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.

Detailed Description: 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.