Overview

This trial is active, not recruiting.

Condition ovarian cancer
Sponsor University of California, Davis
Collaborator National Cancer Institute (NCI)
Start date October 2005
End date December 2016
Trial size 700 participants
Trial identifier NCT00628654, CDR0000583063, P30CA093373, UCD-183, UCD-200513707

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Serum samples will be obtained from volunteers, but no tissue specimens. Volunteers will complete a questionnaire.
Ascites from patients with ovarian, peritoneal, and fallopian tube cancers for basic science studies

Primary Outcomes

Measure
Accuracy of glycan analysis
time frame: one time for healthy volunteers; up to 2 years for patients with cancer

Secondary Outcomes

Measure
Comparison of the new assay to the standard CA 125 assay
time frame: one time for healthy volunteers; up to 2 years for patients with cancer

Eligibility Criteria

Female participants at least 21 years old.

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

Additional Information

Official title Clinical Protocol to Evaluate Glycans Analysis As a Diagnostic Test for Ovarian Cancer
Principal investigator Gary Leiserowitz, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of California, Davis.
Location data was received from the National Cancer Institute and was last updated in June 2016.