A Study of Effect of Megakaryocytes and Platelets in Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Other: Blood draw
- Registration Number
- NCT06011824
- Lead Sponsor
- Mayo Clinic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 23
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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Biopsy Negative Blood draw Female age 18 and above with negative breast biopsy Biopsy positive for carcinoma in situ (ductal, lobular, or other) Blood draw Females age 18 and above with any subtype of breast cancer (ductal, lobular, or other) Metastatic Stage IV Blood draw Females age 18 and above with any subtype of breast cancer, including metastases Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or other) Blood draw Females age 18 and above with any subtype of breast cancer (HER2+, ER/PR, TNBC, BRCA1 +/-, other).
- Primary Outcome Measures
Name Time Method Platelet Counts Baseline Measure of the number of platelets in the blood, reported as platelets per microliter of blood.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Mayo Clinic Health System-Franciscan Healthcare
🇺🇸La Crosse, Wisconsin, United States