Glycan Analysis in Diagnosing Cancer in Women With Ovarian Epithelial Cancer and in Healthy Female Participants
| Status: | Completed |
|---|---|
| Conditions: | Ovarian Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 1/6/2019 |
| Start Date: | October 2005 |
| End Date: | March 10, 2016 |
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.
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.
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
We found this trial at
1
site
2279 45th Street
Sacramento, California 95817
Sacramento, California 95817
(916) 734-5800
Phone: 916-734-3771
University of California Davis Cancer Center At UC Davis Comprehensive Cancer Center, specialized teams of...
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