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CompletedNCT06011824Updated May 2, 2025

A Study of Effect of Megakaryocytes and Platelets in Breast Cancer

An observational study in Breast Cancer, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-02.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
23
Ages
18 Years and older
Sex
Female
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Study summary

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

Read the 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.

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Conditions studied

  • Breast Cancer

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Keywords

  • Megakaryocytes
  • Platelets
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 23 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
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.

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

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)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
23 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Biopsy Negative

    Female age 18 and above with negative breast biopsy

    Other: Blood 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

  • 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

  • Metastatic Stage IV

    Females age 18 and above with any subtype of breast cancer, including metastases

    Other: Blood draw

Interventions

  • OtherBlood 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)

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What researchers measure

Primary outcomes

  1. Platelet Counts

    Measure of the number of platelets in the blood, reported as platelets per microliter of blood.

    Time frame: Baseline

Secondary outcomes

  1. Mean Corpuscular Volume (MCV)

    Measures the average size of red blood cells, reported as femtoliters (fl).

    Time frame: Baseline

  2. Lymphocyte to neutrophil ratio

    Ratio between the neutrophil and lymphocyte counts measured in peripheral blood.

    Time frame: Baseline

  3. 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.

    Time frame: Baseline

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Study locations

1 site
  • Mayo Clinic Health System-Franciscan Healthcare
    La Crosse, Wisconsin 54601, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06011824
Lead sponsor
Mayo Clinic
Responsible party
Sponsor
First posted
Aug 25, 2023
Start date
Aug 29, 2023
Primary completion
Apr 29, 2025
Completion
Apr 29, 2025
Last update
May 2, 2025

Study contacts

Scott H. Okuno, M.D.
principal investigator · Mayo Clinic Health System-Franciscan Healthcare

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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