Breast Cancer
Conditions
Keywords
Megakaryocytes, Platelets
Brief summary
Determining if Megakaryocytes and Platelets are Harmful or Helpful in Breast Cancer Cell Metastasis
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.
Interventions
OTHERBlood 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)
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
* Previous diagnosis with a known platelet disorder such as: Bernard Soulier disease, Jacobsen syndrome, Lowe syndrome, Thrombocytopenia, Thrombotic thrombocytopenic pupura, Von Willebrand disease, or the equivalent. Any condition in which antiplatelet or anticoagulant therapy with one of the following medications is being prescribed: Clopidogrel (Plavix), Warfarin (Coumadin or Jantoven), Prasugrel (Effient), or Ticagrelor (Brilinta). 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 * Less than 30 days from last adjuvant treatment for Stage I-III Breast Cancer (may be on Trastuzumab, Pertuzumab, or endocrine therapy only for maintenance therapy from their prior breast cancer diagnosis)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet Counts | Baseline | Measure of the number of platelets in the blood, reported as platelets per microliter of blood. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed