Summary

for females ages 21 years and up (full criteria)
healthy people welcome
at UC Davis
study started
estimated completion:
Gary Leiserowitz (ucdavis)

Description

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.

Official Title

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

Details

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.

Keywords

Ovarian Cancer ovarian germ cell tumor ovarian epithelial cancer Ovarian Neoplasms Volunteers

Eligibility

For females ages 21 years and up

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

Location

  • University of California Davis Cancer Center accepting new patients
    Sacramento California 95817 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT00628654
Study Type
Observational
Last Updated