A Study of Effect of Megakaryocytes and Platelets in Breast Cancer

October 2, 2023 updated by: Mayo Clinic

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Mayo Clinic Health System-Franciscan Healthcare
        • Contact:
          • Clinical Trials
        • Contact:
        • Principal Investigator:
          • Scott H. Okuno, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Biopsy Negative
Female age 18 and above with negative breast biopsy
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)
Biopsy positive for carcinoma in situ (ductal, lobular, or other)
Females age 18 and above with any subtype of breast cancer (ductal, lobular, or other)
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)
Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or other)
Females age 18 and above with any subtype of breast cancer (HER2+, ER/PR, TNBC, BRCA1 +/-, other).
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)
Metastatic Stage IV
Females age 18 and above with any subtype of breast cancer, including metastases
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet Counts
Time Frame: Baseline
Measure of the number of platelets in the blood, reported as platelets per microliter of blood.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Corpuscular Volume (MCV)
Time Frame: Baseline
Measures the average size of red blood cells, reported as femtoliters (fl).
Baseline
Lymphocyte to neutrophil ratio
Time Frame: Baseline
Ratio between the neutrophil and lymphocyte counts measured in peripheral blood.
Baseline
Levels of tumor educated platelets
Time Frame: 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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Scott H. Okuno, M.D., Mayo Clinic Health System-Franciscan Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2023

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2028

Study Registration Dates

First Submitted

August 8, 2023

First Submitted That Met QC Criteria

August 21, 2023

First Posted (Actual)

August 25, 2023

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-004958

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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