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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 : July 17, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
William Carson, Ohio State University Comprehensive Cancer Center

Brief Summary:
Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients

Condition or disease Intervention/treatment
Breast Cancer Other: Specimen collection

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Study Type : Observational
Estimated Enrollment : 99 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients
Actual Study Start Date : June 4, 2010
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04022616


Contacts
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Contact: Ohio State Comprehensive Cancer Center 1-800-293-5066 OSUCCCClinicaltrials@osumc.edu

Locations
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United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: William Carson, MD Ohio State Comprehensive Cancer Center

Additional Information:
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Responsible Party: William Carson, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04022616     History of Changes
Other Study ID Numbers: OSU-09142
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases