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

Completed

• Conditions: Ovarian Cancer

• Registration Number: NCT00628654
• Lead Sponsor: University of California, Davis

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2008-03-04
• Study First Submitted QC: 2008-03-04
• Study First Posted: 2008-03-05
• Primary Completion: 2016-03-10
• Study Completion: 2016-03-10
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-02
• Last Update Posted: 2019-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 581

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of glycan analysis	one time for healthy volunteers; up to 2 years for patients with cancer	For healthy controls, a single sample will be obtained. For patients scheduled for surgery, two samples will be obtained: one preoperatively and one postoperatively. Ovarian cancer patients who agree to participate in the longitudinal study will have follow-up serum samples drawn periodically during chemotherapy treatments and then during surveillance visits, to correspond with routine blood testing for CA 125. They will be asked to participate for 2 years, with a maximum of 8 blood draws per year (to be coordinated with other venipunctures, if possible).

Secondary Outcome Measures

Name	Time	Method
Comparison of the new assay to the standard CA 125 assay	one time for healthy volunteers; up to 2 years for patients with cancer	For healthy controls, a single sample will be obtained. For patients scheduled for surgery, two samples will be obtained: one preoperatively and one postoperatively. Ovarian cancer patients who agree to participate in the longitudinal study will have follow-up serum samples drawn periodically during chemotherapy treatments and then during surveillance visits, to correspond with routine blood testing for CA 125. They will be asked to participate for 2 years, with a maximum of 8 blood draws per year (to be coordinated with other venipunctures, if possible).

Trial Locations

Locations (1)

University of California Davis Cancer Center; 🇺🇸 Sacramento, California, United States