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

January 2, 2019 updated by: University of California, Davis

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

581

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California Davis Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

volunteers and patients with ovarian, peritoneal, and fallopian tube cancers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Volunteers
Serum samples will be obtained from volunteers, but no tissue specimens. Volunteers will complete a questionnaire.
Patients with cancer
Ascites from patients with ovarian, peritoneal, and fallopian tube cancers for basic science studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of glycan analysis
Time Frame: 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).
one time for healthy volunteers; up to 2 years for patients with cancer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Gary Leiserowitz, MD, University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

March 10, 2016

Study Completion (Actual)

March 10, 2016

Study Registration Dates

First Submitted

March 4, 2008

First Submitted That Met QC Criteria

March 4, 2008

First Posted (Estimate)

March 5, 2008

Study Record Updates

Last Update Posted (Actual)

January 4, 2019

Last Update Submitted That Met QC Criteria

January 2, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 251975
  • P30CA093373 (U.S. NIH Grant/Contract)
  • CDR0000583063 (Other Identifier: UC Davis IRB)
  • UCD-183 (Other Identifier: University of California Davis)
  • UCD-200513707 (Other Identifier: University of California Davis)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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