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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00628654

Enrollment

581

Registered

2008-03-05

Start date

2005-10-31

Completion date

2016-03-10

Last updated

2019-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

ovarian germ cell tumor, ovarian epithelial cancer

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.

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Accuracy of glycan analysis	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).

Secondary

Measure	Time frame	Description
Comparison of the new assay to the standard CA 125 assay	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).

Countries

United States

Outcome results