A Study of Effect of Megakaryocytes and Platelets in Breast Cancer
NCT ID: NCT06011824
Last Updated: 2025-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
23 participants
OBSERVATIONAL
2023-08-29
2025-04-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Biopsy Negative
Female age 18 and above with negative breast biopsy
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)
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).
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
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
FEMALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Scott H. Okuno, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic Health System-Franciscan Healthcare
Locations
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Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2023-06775
Identifier Type: REGISTRY
Identifier Source: secondary_id
23-004958
Identifier Type: -
Identifier Source: org_study_id
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