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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-06775 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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Determining if Megakaryocytes and Platelets are Harmful or Helpful in Breast Cancer Cell Metastasis
The purpose of this study is to determine how megakaryocytes (cells in the bone marrow responsible for making platelets, which are necessary for blood clotting) affect the survival and growth/division patterns of breast cancer stem cells, and the effects of breast cancer cells on megakaryocyte survival and function. Through chart review, the study team will look at the relationship between different blood components and different breast cancer diagnoses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biopsy Negative | Female age 18 and above with negative breast biopsy |
| |
| Biopsy positive for carcinoma in situ (ductal, lobular, or other) | Females age 18 and above with any subtype of breast cancer (ductal, lobular, or other) |
| |
| Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or other) | Females age 18 and above with any subtype of breast cancer (HER2+, ER/PR, TNBC, BRCA1 +/-, other). |
| |
| Metastatic Stage IV | Females age 18 and above with any subtype of breast cancer, including metastases |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood draw | Other | 10-12mL of blood will be drawn one time, unless a redraw is needed, in which case up to 24 mL will be drawn (10-12 mL each draw) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Platelet Counts | Measure of the number of platelets in the blood, reported as platelets per microliter of blood. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Corpuscular Volume (MCV) | Measures the average size of red blood cells, reported as femtoliters (fl). | Baseline |
| Lymphocyte to neutrophil ratio | Ratio between the neutrophil and lymphocyte counts measured in peripheral blood. |
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Inclusion Criteria:
Cohort 1-Biopsy negative
Cohort 2-Biopsy positive for carcinoma in situ (ductal, lobular, or other)
Cohort 3-Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or other)
Cohort 4-Stage 4 Metastatic Disease
Exclusion Criteria:
Cohort 1-Biopsy negative
Cohort 2-Biopsy positive for carcinoma in situ (ductal, lobular, or other)
Cohort 3-Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or other)
Cohort 4-Stage 4 Metastatic Disease
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Biological females
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For the prospective study: 20 women after biopsy for suspicious mammogram findings, 10 women with newly diagnosed metastatic cancer.
Subject population (children, adults, groups): Women undergoing biopsy or suspicious mammogram finds and newly diagnosed female metastatic breast cancer patients.
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| Name | Affiliation | Role |
|---|---|---|
| Scott H. Okuno, M.D. | Mayo Clinic Health System-Franciscan Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Health System-Franciscan Healthcare | La Crosse | Wisconsin | 54601 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Blood draw. 10-12 mL total into lavender-top (EDTA) tubes, however up to 24 mL may be obtained should a redraw be needed.
| Baseline |
| Levels of tumor educated platelets | Number of tumor educated platelets, measured by the analysis of cell surface markers for expression of certain markers such as VEGF, PDGFR, MMP1, TGFb, and or other cell adhesion molecules. | Baseline |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |