A Pilot Study of Tumor-Derived Exosomes as Diagnostic and Prognostic Markers in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- To characterize protein surface markers and RNA profiles in tumor derived exosomes from breast cancer patients undergoing neoadjuvant chemotherapy
研究概览
简要总结
This is a pilot study evaluating the use of tumor derived exosomes as a marker for response to therapy in women receiving neoadjuvant chemotherapy for newly diagnosed breast cancer. Tumor derived exosome analysis may be a novel diagnostic and prognostic biosignature in breast cancer, which could prove to be a tool for earlier diagnosis, more effective treatments, and improved markers of response in order to increase survival rates.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •Women with biopsy proven invasive carcinoma of the breast
- •Women with locally advanced breast cancer and breast tumors measuring >/= 2cm who are deemed candidates for preoperative chemotherapy
- •Age >/= 18 years old
- •Expected survival >/= 6 months
- •Eastern Cooperative Oncology Group performance status of 0, 1, or 2 at initiation of study
- •Initial required laboratory values:
- •Absolute neutrophil count >/= 1.5 x 10(9)/L Platelet count >/= 100,000 x 10(9)/L Creatinine clearance >/= 50mL/min (calculated by Cockcroft-Gault method) Liver function tests (AST, ALT, total bilirubin) </= 2.5 x ULN Urine or serum HCG negative (if female of childbearing potential)
- •Women may be enrolled on ongoing therapeutic preoperative chemotherapy trials
排除标准
- •No prior chemotherapy for breast cancer
- •No limitations for prior radiation therapy
- •No active, serious infection or medical or psychiatric illness likely to interfere with participation in this trial
- •Non-pregnant and non-nursing patients only. Patients of reproductive potential must agree to use an effective means of birth control
- •No prior liver transplant or bone marrow transplant
结局指标
主要结局
To characterize protein surface markers and RNA profiles in tumor derived exosomes from breast cancer patients undergoing neoadjuvant chemotherapy
时间窗: up to 2 years from start of study
Compare tumor derived exosomes at baseline, monthly during chemotherapy, at the completion of chemotherapy treatment, and after surgery to determine residual cancer burden. Tumor derived exosome expression will be correlated with both clinical and pathologic response.
次要结局
未报告次要终点
研究者
Susan E. Eubanks, RN, MSN, OCN
Clinical Trials Manager
Leo W. Jenkins Cancer Center