Glycan Analysis in Diagnosing Cancer in Women With Ovarian Epithelial Cancer and in Healthy Female Participants
This study is currently recruiting participants.
Verified March 2013 by University of California, Davis
Sponsor:
University of California, Davis
Collaborator:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00628654
First received: March 4, 2008
Last updated: March 11, 2013
Last verified: March 2013
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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 2014 |
| Estimated Primary Completion Date: | December 2013 (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
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: | March 11, 2013 |
| 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 Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 19, 2013