Glycan Analysis in Diagnosing Cancer in Women With Ovarian Epithelial Cancer and in Healthy Female Participants
Clinical Protocol to Evaluate Glycans Analysis As a Diagnostic Test for Ovarian Cancer
5 other identifiers
observational
581
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2005
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 4, 2008
CompletedFirst Posted
Study publicly available on registry
March 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2016
CompletedJanuary 4, 2019
January 1, 2019
10.4 years
March 4, 2008
January 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Accuracy of glycan analysis
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 Outcomes (1)
Comparison of the new assay to the standard CA 125 assay
one time for healthy volunteers; up to 2 years for patients with cancer
Study Arms (2)
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
Eligibility Criteria
volunteers and patients with ovarian, peritoneal, and fallopian tube cancers
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Davislead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of California Davis Cancer Center
Sacramento, California, 95817, United States
Biospecimen
Blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gary Leiserowitz, MD
University of California, Davis
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2008
First Posted
March 5, 2008
Study Start
October 1, 2005
Primary Completion
March 10, 2016
Study Completion
March 10, 2016
Last Updated
January 4, 2019
Record last verified: 2019-01