Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients
April 1, 2026 updated by: William Carson, Ohio State University Comprehensive Cancer Center
Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients
Study Overview
Study Type
Observational
Enrollment (Estimated)
99
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
- Name: Ohio State Comprehensive Cancer Center
- Phone Number: 1-800-293-5066
- Email: OSUCCCClinicaltrials@osumc.edu
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- Recruiting
- Ohio State University Comprehensive Cancer Center
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients who are being treated at the Ohio State Comprehensive Cancer Center and Stefanie Spielman Comprehensive Breast Center
Description
Inclusion Criteria:
- 18 years of age or older
- Ability to give informed consent
- Stage I-III breast malignancy
Exclusion Criteria:
- Unable to tolerate venipuncture
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Immediate Surgery
Adult patients with breast malignancy.
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Specimens are obtained from patients who are being treated for breast malignancies.
|
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Neo-adjuvant Chemotherapy
Adult patients with biopsy proven operable breast cancer who in the opinion of treating physician are suited to receive neo-adjuvant chemotherapy.
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Specimens are obtained from patients who are being treated for breast malignancies.
|
|
Lymph Node Tissue
Adult patients with breast malignancy who will be having a primary lymph node removed during breast surgery.
|
Specimens are obtained from patients who are being treated for breast malignancies.
|
|
Metastatic Breast Cancer
Adult patients with biopsy proven stage IV breast cancer who are starting a new line palliative systemic therapy.
A palliative systemic therapy will be defined in this trial as any chemotherapy regimen or combination of endocrine therapy with targeted agents such as cyclin dependent kinase 4/6 (CDK 4/6) inhibitors, HER2 targeting agents or inhibitors of mammalian target of rapamycin (mTOR).
|
Specimens are obtained from patients who are being treated for breast malignancies.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Isolate unfavorable immune cells MDSC from the peripheral blood or tumors of study subjects and test how strongly they inhibit function of favorable immune cells called Natural Killer Cells.
Time Frame: up to 1 year
|
Function of Natural Killer Cells will be studied by measuring their ability to kill target cancer cells coated with monoclonal antibodies. isolate unfavorable immune cells called Myeloid Derived Suppressor Cells (MDSC) from the peripheral blood or the tumors of study subjects and test how strongly they inhibit function of favorable immune cells called Natural Killer Cells. Function of Natural Killer Cells will be studied by measuring their ability to kill target cancer cells coated with monoclonal antibodies. |
up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Isolate unfavorable immune cells called Myeloid Derived Suppressor Cells (MDSC) from the peripheral blood of study subjects who plan to start pre-operative chemotherapy for breast cancer to see if MDSC levels can predict who will respond to treatment. W
Time Frame: up to 1 year
|
Percentage of MDSC at baseline and whether there is an association of baseline MDSC percent with response to chemotherapy.
|
up to 1 year
|
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Isolate unfavorable immune cells MDSC from peripheral blood of study subjects who receive pre-operative chemotherapy for breast cancer to identify changes in MDSC levels during treatment can predict who will respond to treatment.
Time Frame: up to 1 year
|
Changes will be reported in percentage of MDSC and associations of such changes with response to chemotherapy.
|
up to 1 year
|
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Isolate lymph nodes from patients with breast cancer undergoing breast surgery to study what types of Natural Killer Cells are present.
Time Frame: up to 1 year
|
Isolate a lymph nodes from patients with breast cancer undergoing breast surgery to study what types of Natural Killer Cells are present.
Natural Killer cells are immune cells that are capable of killing cancer cells.
|
up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: William Carson, MD, Ohio State Comprehensive Cancer Center
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)
June 4, 2010
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
June 15, 2019
First Submitted That Met QC Criteria
July 13, 2019
First Posted (Actual)
July 17, 2019
Study Record Updates
Last Update Posted (Actual)
April 6, 2026
Last Update Submitted That Met QC Criteria
April 1, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSU-09142
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.