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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000583063 | Other Identifier | UC Davis IRB | |
| UCD-183 | Other Identifier | University of California Davis | |
| UCD-200513707 | Other Identifier | University of California Davis | |
| P30CA093373 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE:
PROJECTED ACCRUAL: A total of 300 healthy female participants and 400 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the new assay to the standard CA 125 assay | 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). |
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Inclusion Criteria:
Participants must meet 1 of the following criteria:
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volunteers and patients with ovarian, peritoneal, and fallopian tube cancers
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| Name | Affiliation | Role |
|---|---|---|
| Gary Leiserowitz, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis Cancer Center | Sacramento | California | 95817 | United States |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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Blood samples
| one time for healthy volunteers; up to 2 years for patients with cancer |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |