View Clinical Trial (Medical Research Study)
Clinical Protocol to Evaluate Glycans Analysis As a Diagnostic Test for Ovarian Cancer
| City: |
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Sacramento |
| State: |
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California |
| Zip Code: |
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95817 |
| Conditions: |
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Ovarian Cancer |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| 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
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| NCT ID: |
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NCT00628654 |
| Primary Contact: |
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Principal Investigator
Gary Leiserowitz, MD
University of California, Davis
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| Backup Contact: |
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N/A |
| Location Contact: |
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Sacramento, California 95817
United States
Gary Leiserowitz, MD
Phone: 916-734-3771
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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