A Study of Effect of Megakaryocytes and Platelets in Breast Cancer

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06011824
• Lead Sponsor: Mayo Clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-8-8
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Inclusion Criteria:<br><br>Cohort 1-Biopsy negative<br><br> - Females age 18 and above<br><br>Cohort 2-Biopsy positive for carcinoma in situ (ductal, lobular, or other)<br><br> - Females age 18 and above<br><br> - Any subtype of breast cancer<br><br>Cohort 3-Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or<br>other)<br><br> - Females age 18 and above<br><br> - Any subtype of breast cancer<br><br> - Have no distant metastases<br><br>Cohort 4-Stage 4 Metastatic Disease<br><br> - Females age 18 and above<br><br> - Any subtype of breast cancer<br><br>Exclusion Criteria:<br><br> - Previous diagnosis with a known platelet disorder such as: Bernard Soulier disease,<br> Jacobsen syndrome, Lowe syndrome, Thrombocytopenia, Thrombotic thrombocytopenic<br> pupura, Von Willebrand disease, or the equivalent. Any condition in which<br> antiplatelet or anticoagulant therapy with one of the following medications is being<br> prescribed: Clopidogrel (Plavix), Warfarin (Coumadin or Jantoven), Prasugrel<br> (Effient), or Ticagrelor (Brilinta).<br><br>Cohort 1-Biopsy negative<br><br> - Males<br><br> - Females less than age 18<br><br>Cohort 2-Biopsy positive for carcinoma in situ (ductal, lobular, or other)<br><br> - Males<br><br> - Females less than age 18<br><br> - Currently undergoing neoadjuvant therapy<br><br>Cohort 3-Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or<br>other)<br><br> - Males<br><br> - Females less than age 18<br><br> - Presence of distant metastases<br><br> - Currently undergoing neoadjuvant therapy<br><br>Cohort 4-Stage 4 Metastatic Disease<br><br> - Males<br><br> - Females less than age 18<br><br> - Currently undergoing neoadjuvant therapy<br><br> - Less than 30 days from last adjuvant treatment for Stage I-III Breast Cancer (may be<br> on Trastuzumab, Pertuzumab, or endocrine therapy only for maintenance therapy from<br> their prior breast cancer diagnosis)

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Platelet Counts

Secondary Outcome Measures

Name	Time	Method
Mean Corpuscular Volume (MCV);Lymphocyte to neutrophil ratio;Levels of tumor educated platelets