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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ovarian Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Volunteers<br>Serum samples will be obtained from volunteers, but no tissue specimens. Volunteers will complete a questionnaire. | |
| Patients with cancer<br>Ascites from patients with ovarian, peritoneal, and fallopian tube cancers for basic science studies | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the new assay to the standard CA 125 assay | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian germ cell tumor, ovarian epithelial cancer