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


N/A
21 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Accuracy of glycan analysis

Outcome Description:

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).

Outcome Time Frame:

one time for healthy volunteers; up to 2 years for patients with cancer

Safety Issue:

No

Principal Investigator

Gary Leiserowitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Davis

Authority:

United States: Institutional Review Board

Study ID:

CDR0000583063

NCT ID:

NCT00628654

Start Date:

October 2005

Completion Date:

December 2014

Related Keywords:

  • Ovarian Cancer
  • ovarian germ cell tumor
  • ovarian epithelial cancer
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location
University of California Davis Cancer Center Sacramento, California  95817