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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-02554 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 74A14 | |||
| CCCWFU 74A14 | |||
| CCCWFU 74A14 | Other Identifier | Wake Forest University Health Sciences | |
| R01CA173499 | U.S. NIH Grant/Contract | View source | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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Logistical Issues
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This research trial studies the role of a substance called hyaluronic acid in causing the growth of cancer stem cells in the bones of patients with breast cancer. Cancer stem cells are a type of cancer cells that may cause the cancer to spread to other parts of the body. Studying samples of blood and bone marrow from patients and animal models in the laboratory may help doctors learn more about whether hyaluronic acid affects the growth of cancer in the bones.
PRIMARY OBJECTIVES:
I. To evaluate the hypothesis that there are more hyaluronan synthase 2 (HAS2)+ cells in patients with bone metastasis compared to patients with only local disease.
SECONDARY OBJECTIVES:
I. To evaluate the hypothesis that cells with HAS2+ and cancer stem cell (CSC)+ (cluster of differentiation [CD]24-/CD44+/epithelial specific antigen [ESA]+) cells will have the most aggressive growth in the bone, using an animal model.
OUTLINE:
Blood and bone marrow samples are collected and analyzed via flow cytometry and polymerase chain reaction (PCR). Cells are also transplanted into mice and studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ancillary-correlative (role of HAS2+ in CSCs) | Blood and bone marrow samples are collected and analyzed via flow cytometry and PCR. Cells are also transplanted into mice and studied. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytology Specimen Collection Procedure | Other | Correlative studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| HAS2 expression, measured by single-cell PCR | Descriptive statistics will be generated. The relationship of each cell's bone metastatic ability and HAS2 expression will be examined using correlations within each group between these two measures. The mean values of the HAS2 expression and bone metastatic ability will be compared between groups using one-way analysis of variance (ANOVA) models. In addition, 2-sample t-tests will be used to compare the primary cancer and bone metastases groups. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| CSC marker expression | Expression of CSC markers including CD24, CD44 and ESA will be examined. These will also be examined using descriptive statistics and compared with each other using one-way ANOVA models and 2-sample t-tests to compare the primary cancer and bone metastases groups. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with newly diagnosed, histologically confirmed primary and/or metastatic breast cancer
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| Name | Affiliation | Role |
|---|---|---|
| Kounosuke Watabe | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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