Breast CancerNCT06011824
A Study of Effect of Megakaryocytes and Platelets in Breast Cancer
An observational study of Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
Determining if Megakaryocytes and Platelets are Harmful or Helpful in Breast Cancer Cell Metastasis Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Blood draw
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2023to 29 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
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.
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601
About this study
Official title: 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
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.
- Conditions
- Breast Cancer
- Being tested
- Blood draw
- Keywords
- Megakaryocytes, Platelets
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Biopsy Negative | Female age 18 and above with negative breast biopsy Receives: 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) Receives: 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). Receives: Other: Blood draw | |
| Metastatic Stage IV | Females age 18 and above with any subtype of breast cancer, including metastases Receives: Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Counts
Measure of the number of platelets in the blood, reported as platelets per microliter of blood.
Measured: Baseline
Secondary outcomes (3)
Mean Corpuscular Volume (MCV)
Measures the average size of red blood cells, reported as femtoliters (fl).
Measured: Baseline
Lymphocyte to neutrophil ratio
Ratio between the neutrophil and lymphocyte counts measured in peripheral blood.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start29 Aug 2023
- Primary completion29 Apr 2025
- Study completion29 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott H. Okuno, M.D., Principal investigator, Mayo Clinic Health System-Franciscan Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011824
- Sponsor's protocol ID
- 23-004958
- Other IDs
- NCI-2023-06775
- Status last verified
- Apr 2025
- First submitted
- 8 Aug 2023
- Last updated
- 2 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Megakaryocytes and Platelets, Harmful or Helpful in Breast Cancer Cell Metastasis
- ClinicalTrials.gov ID
- NCT06011824
- Acronym / sponsor ID
- 23-004958
- Conditions
- Breast Cancer
- Keywords
- Megakaryocytes, Platelets
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 29 Aug 2023 (actual)
- Primary completion
- 29 Apr 2025 (actual)
- Study completion
- 29 Apr 2025 (actual)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Biopsy Negative | – | Other: Blood drawFemale age 18 and above with negative breast biopsy |
| Biopsy positive for carcinoma in situ (ductal, lobular, or other) | – | Other: Blood drawFemales age 18 and above with any subtype of breast cancer (ductal, lobular, or other) |
| Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or other) | – | Other: Blood drawFemales age 18 and above with any subtype of breast cancer (HER2+, ER/PR, TNBC, BRCA1 +/-, other). |
| Metastatic Stage IV | – | Other: Blood drawFemales age 18 and above with any subtype of breast cancer, including metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draw10-12mL 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) | Other | Biopsy Negative, Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or other), Biopsy positive for carcinoma in situ (ductal, lobular, or other), Metastatic Stage IV |
Primary outcome
Platelet Counts
Time frame: Baseline
Measure of the number of platelets in the blood, reported as platelets per microliter of blood.
3 secondary outcomes
Mean Corpuscular Volume (MCV)
Time frame: Baseline
Lymphocyte to neutrophil ratio
Time frame: Baseline
Levels of tumor educated platelets
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott H. Okuno, M.D. principal investigator
Mayo Clinic Health System-Franciscan Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet Counts (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.