Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients

March 7, 2024 updated by: William Carson, Ohio State University Comprehensive Cancer Center
Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center

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.
Other: Specimen collection
Specimens are obtained from patients who are being treated for breast malignancies.
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.
Other: Specimen collection
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.
Other: Specimen collection
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).
Other: Specimen collection
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
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
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.

Sponsor

Ohio State University Comprehensive Cancer Center

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.

General Publications

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, 2024

Study Completion (Estimated)

December 31, 2024

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)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

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.

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