A Study of Effect of Megakaryocytes and Platelets in Breast Cancer

Breast Cancer Clinical Trial

Official title:

Megakaryocytes and Platelets, Harmful or Helpful in Breast Cancer Cell Metastasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06011824
• Other study ID #: 23-004958
• Status: Recruiting
• Start date: August 29, 2023
• Est. completion date: September 30, 2028

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: Clinical Trials Referral Office
• Phone: 855-776-0015
• Email: mayocliniccancerstudies[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Determining if Megakaryocytes and Platelets are Harmful or Helpful in Breast Cancer Cell Metastasis

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 30, 2028
• Est. primary completion date: September 30, 2028
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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)

Locations

Country	Name	City	State
United States	Mayo Clinic Health System-Franciscan Healthcare	La Crosse	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet Counts	Measure of the number of platelets in the blood, reported as platelets per microliter of blood.	Baseline
Secondary	Mean Corpuscular Volume (MCV)	Measures the average size of red blood cells, reported as femtoliters (fl).	Baseline
Secondary	Lymphocyte to neutrophil ratio	Ratio between the neutrophil and lymphocyte counts measured in peripheral blood.	Baseline
Secondary	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

External Links

•   Mayo Clinic Clinical Trials