Glycan Analysis in Diagnosing Cancer in Women With Ovarian Epithelial Cancer and in Healthy Female Participants
NCT ID: NCT00628654
Last Updated: 2019-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
581 participants
OBSERVATIONAL
2005-10-31
2016-03-10
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Volunteers
Serum samples will be obtained from volunteers, but no tissue specimens. Volunteers will complete a questionnaire.
No interventions assigned to this group
Patients with cancer
Ascites from patients with ovarian, peritoneal, and fallopian tube cancers for basic science studies
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
21 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
University of California, Davis
OTHER
Responsible Party
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Principal Investigators
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Gary Leiserowitz, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
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University of California Davis Cancer Center
Sacramento, California, United States
Countries
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Other Identifiers
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CDR0000583063
Identifier Type: OTHER
Identifier Source: secondary_id
UCD-183
Identifier Type: OTHER
Identifier Source: secondary_id
UCD-200513707
Identifier Type: OTHER
Identifier Source: secondary_id
251975
Identifier Type: -
Identifier Source: org_study_id
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