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

Ovarian Cancer Clinical Trial

Official title:

Clinical Protocol to Evaluate Glycans Analysis As a Diagnostic Test for Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628654
• Other study ID #: 251975
• Secondary ID: CDR0000583063UCD
• Status: Completed
• Start date: October 2005
• Est. completion date: March 10, 2016

Study information

• Verified date: January 2019
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 581
• Est. completion date: March 10, 2016
• Est. primary completion date: March 10, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
United States	University of California Davis Cancer Center	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of glycan analysis	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).	one time for healthy volunteers; up to 2 years for patients with cancer
Secondary	Comparison of the new assay to the standard CA 125 assay	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).	one time for healthy volunteers; up to 2 years for patients with cancer