Ovarian Cancer Clinical Trial

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

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.

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Full 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.

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Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

581

Study ID:

NCT00628654

Recruitment Status:

Completed

Sponsor:

University of California, Davis

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There is 1 Location for this study

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University of California Davis Cancer Center
Sacramento California, 95817, United States

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Study is for people with:

Ovarian Cancer

Estimated Enrollment:

581

Study ID:

NCT00628654

Recruitment Status:

Completed

Sponsor:


University of California, Davis

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