Breast Cancer Clinical Trial
Official title:
Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients
| NCT number | NCT04022616 |
| Other study ID # | OSU-09142 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 4, 2010 |
| Est. completion date | December 31, 2024 |
Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients
| Status | Recruiting |
| Enrollment | 99 |
| Est. completion date | December 31, 2024 |
| Est. primary completion date | December 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 18 years of age or older - Ability to give informed consent - Stage I-III breast malignancy Exclusion Criteria: - Unable to tolerate venipuncture |
| Country | Name | City | State |
|---|---|---|---|
| United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Ohio State University Comprehensive Cancer Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 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 | 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 | Percentage of MDSC at baseline and whether there is an association of baseline MDSC percent with response to chemotherapy. | up to 1 year | |
| Secondary | 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. | Changes will be reported in percentage of MDSC and associations of such changes with response to chemotherapy. | up to 1 year | |
| Secondary | Isolate lymph nodes from patients with breast cancer undergoing breast surgery to study what types of Natural Killer Cells are present. | 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 |
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