A Study of Effect of Megakaryocytes and Platelets in Breast Cancer

NCT06011824 | Completed

• 2 other identifiers: 23-004958NCI-2023-06775
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

Megakaryocytes; Platelets

Outcome Measures

Primary Outcomes (1)

• Platelet Counts

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

  Baseline

Secondary Outcomes (3)

• Mean Corpuscular Volume (MCV)

  Baseline

• Lymphocyte to neutrophil ratio

  Baseline

• Levels of tumor educated platelets

  Baseline

Study Arms (4)

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

Blood draw OTHER

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 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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Biological females
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, 54601, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Blood draw. 10-12 mL total into lavender-top (EDTA) tubes, however up to 24 mL may be obtained should a redraw be needed.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Scott H. Okuno, M.D.

  Mayo Clinic Health System-Franciscan Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 25, 2023
• Study Start: August 29, 2023
• Primary Completion: April 29, 2025
• Study Completion: April 29, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Locations

US (1)