A Study of Effect of Megakaryocytes and Platelets in Breast Cancer
Study Details
Study Description
Brief Summary
Determining if Megakaryocytes and Platelets are Harmful or Helpful in Breast Cancer Cell Metastasis
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Biopsy Negative Female age 18 and above with negative breast biopsy |
Other: Blood draw
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)
|
| 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) |
Other: Blood draw
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)
|
| 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). |
Other: Blood draw
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)
|
| Metastatic Stage IV Females age 18 and above with any subtype of breast cancer, including metastases |
Other: Blood draw
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)
|
Outcome Measures
Primary Outcome Measures
- Platelet Counts [Baseline]
Measure of the number of platelets in the blood, reported as platelets per microliter of blood.
Secondary Outcome Measures
- Mean Corpuscular Volume (MCV) [Baseline]
Measures the average size of red blood cells, reported as femtoliters (fl).
- Lymphocyte to neutrophil ratio [Baseline]
Ratio between the neutrophil and lymphocyte counts measured in peripheral blood.
- Levels of tumor educated platelets [Baseline]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
Cohort 1-Biopsy negative
-Females age 18 and above
Cohort 2-Biopsy positive for carcinoma in situ (ductal, lobular, or other)
-
Females age 18 and above
-
Any subtype of breast cancer
Cohort 3-Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or other)
-
Females age 18 and above
-
Any subtype of breast cancer
-
Have no distant metastases
Cohort 4-Stage 4 Metastatic Disease
-
Females age 18 and above
-
Any subtype of breast cancer
Exclusion Criteria:
Cohort 1-Biopsy negative
-
Males
-
Females less than age 18
Cohort 2-Biopsy positive for carcinoma in situ (ductal, lobular, or other)
-
Males
-
Females less than age 18
-
Currently undergoing neoadjuvant therapy
Cohort 3-Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or other)
-
Males
-
Females less than age 18
-
Presence of distant metastases
-
Currently undergoing neoadjuvant therapy
Cohort 4-Stage 4 Metastatic Disease
-
Males
-
Females less than age 18
-
Currently undergoing neoadjuvant therapy
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Scott H. Okuno, M.D., Mayo Clinic Health System-Franciscan Healthcare
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 23-004958