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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of California, Davis
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00628654
First received: March 4, 2008
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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.


Condition
Ovarian Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Clinical Protocol to Evaluate Glycans Analysis As a Diagnostic Test for Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Accuracy of glycan analysis [ Time Frame: one time for healthy volunteers; up to 2 years for patients with cancer ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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).


Biospecimen Retention:   Samples With DNA

Blood samples


Estimated Enrollment: 700
Study Start Date: October 2005
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628654

Locations
United States, California
University of California Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Gary Leiserowitz, MD    916-734-3771      
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Gary Leiserowitz, MD University of California, Davis
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00628654     History of Changes
Other Study ID Numbers: CDR0000583063, P30CA093373, UCD-183, UCD-200513707
Study First Received: March 4, 2008
Last Updated: July 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
ovarian germ cell tumor
ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014