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Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT04022616
Recruitment Status : Recruiting
First Posted : July 17, 2019
Last Update Posted : March 31, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
William Carson, Ohio State University Comprehensive Cancer Center

Tracking Information
First Submitted Date June 15, 2019
First Posted Date July 17, 2019
Last Update Posted Date March 31, 2020
Actual Study Start Date June 4, 2010
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 13, 2019)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 13, 2019)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients
Official Title Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients
Brief Summary Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients who are being treated at the Ohio State Comprehensive Cancer Center and Stefanie Spielman Comprehensive Breast Center
Condition Breast Cancer
Intervention Other: Specimen collection
Specimens are obtained from patients who are being treated for breast malignancies.
Study Groups/Cohorts
  • Immediate Surgery
    Adult patients with breast malignancy.
    Intervention: Other: Specimen collection
  • 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.
    Intervention: Other: Specimen collection
  • Lymph Node Tissue
    Adult patients with breast malignancy who will be having a primary lymph node removed during breast surgery.
    Intervention: Other: Specimen collection
  • 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).
    Intervention: Other: Specimen collection
Publications * Wesolowski R, Stiff A, Quiroga D, McQuinn C, Li Z, Nitta H, Savardekar H, Benner B, Ramaswamy B, Lustberg M, Layman RM, Macrae E, Kassem M, Williams N, Sardesai S, VanDeusen J, Stover D, Cherian M, Mace TA, Yu L, Duggan M, Carson WE 3rd. Exploratory analysis of immune checkpoint receptor expression by circulating T cells and tumor specimens in patients receiving neo-adjuvant chemotherapy for operable breast cancer. BMC Cancer. 2020 May 19;20(1):445. doi: 10.1186/s12885-020-06949-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 13, 2019)
99
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Ability to give informed consent
  • Stage I-III breast malignancy

Exclusion Criteria:

  • Unable to tolerate venipuncture
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ohio State Comprehensive Cancer Center 1-800-293-5066 OSUCCCClinicaltrials@osumc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04022616
Other Study ID Numbers OSU-09142
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party William Carson, Ohio State University Comprehensive Cancer Center
Study Sponsor Ohio State University Comprehensive Cancer Center
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: William Carson, MD Ohio State Comprehensive Cancer Center
PRS Account Ohio State University Comprehensive Cancer Center
Verification Date March 2020