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Trial Title:
A Study of Effect of Megakaryocytes and Platelets in Breast Cancer
NCT ID:
NCT06011824
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Megakaryocytes
Platelets
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Blood draw
Description:
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)
Arm group label:
Biopsy Negative
Arm group label:
Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or other)
Arm group label:
Biopsy positive for carcinoma in situ (ductal, lobular, or other)
Arm group label:
Metastatic Stage IV
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.
Criteria for eligibility:
Study pop:
For the prospective study: 20 women after biopsy for suspicious mammogram findings, 10
women with newly diagnosed metastatic cancer.
Subject population (children, adults, groups): Women undergoing biopsy or suspicious
mammogram finds and newly diagnosed female metastatic breast cancer patients.
Sampling method:
Non-Probability Sample
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:
- 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)
Gender:
Female
Gender based:
Yes
Gender description:
Biological females
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Mayo Clinic Health System-Franciscan Healthcare
Address:
City:
La Crosse
Zip:
54601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials
Contact backup:
Last name:
Leandra Pake
Phone:
608-392-9719
Email:
Franzen.Leandra@mayo.edu
Investigator:
Last name:
Scott H. Okuno, M.D.
Email:
Principal Investigator
Start date:
August 29, 2023
Completion date:
September 30, 2028
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06011824
https://www.mayo.edu/research/clinical-trials
