Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Ability to give informed consent
- •Stage I-III breast malignancy
排除标准
- •Unable to tolerate venipuncture
研究组 & 干预措施
Immediate Surgery
Adult patients with breast malignancy.
干预措施: Specimen collection (Other)
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.
干预措施: Specimen collection (Other)
Lymph Node Tissue
Adult patients with breast malignancy who will be having a primary lymph node removed during breast surgery.
干预措施: Specimen collection (Other)
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).
干预措施: Specimen collection (Other)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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(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.(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.(up to 1 year)
研究者
William Carson
Principal Investigator
Ohio State University Comprehensive Cancer Center