Heat Shock Protein (HSP) 70 to Quantify and Characterize Circulating Tumor Cells in Patients With Advanced or Metastatic Tumors.
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Radiographic response to initial treatment
研究概览
简要总结
This study investigates the ability of heat shock protein HSP70 to isolate and quantify circulating tumor cells (CTCs) in patients with advanced or metastatic tumors.
CTCs will be isolated from peripheral blood before antineoplastic treatment and again after three months. Isolation using HSP70 will be compared with standard CTC isolation by EpCAM.
Additionally, imaging parameters of the primary tumor (if available) and metastases will be analysed and correlations between molecular alterations and imaging parameters will be assesed.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic malignant melanoma (stage IV)
- •Metastatic or unresectable pancreatic adenocarcinoma (stage III or IV)
- •Metastatic breast cancer
- •Metastatic sarcoma
- •Metastatic squamous cell carcinoma of the cervix uteri, head and neck region, vulva, anus or penis
- •hormone-refractory prostate cancer
排除标准
- •psychiatric disorders that impede adequate informed consent
结局指标
主要结局
Radiographic response to initial treatment
时间窗: 3 months after study enrollment
radiographic response to treatment will be scored according to RECIST criteria and associated with the number of CTC
次要结局
- Correlation between number of CTC isolated with HSP70 compared to EpCAM(3 months (at both CTC assessment timepoints))
- Overall survival(2 years)
- Correlation between differential expressed radiommic parameters between primary tumor and metastases and genetic alterations of the primary tumor and CTCs(3 months (at both CTC assessment timepoints))
- Progression free survival(2 years)
研究者
Sebastian Zschaeck
Doctor Sebastian Zschaeck, principal investigator
Charite University, Berlin, Germany