Liquid Biopsy in Paraneoplastic Neurological Syndromes With High- and Intermediate-Risk Antibodies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- CTC detection
研究概览
简要总结
The main objective of the study is to assess whether circulating tumor cells (CTCs) can be detected in the peripheral blood of patients with paraneoplastic neurological syndromes (PNS) by diagnostic leukapheresis (DLA) combined with the CELLSEARCH® System during clinical routine workup. If CTCs can be identified, a detailed molecular genetic analysis will be performed to characterize mutations in oncogenes and tumor suppressor genes. In addition, the study aims to analyze cell-free DNA (cfDNA) in serum of patients.
Individuals with PNS and high- or intermediate-risk or GAD65-antibodies with a detectable tumor (PNS+T), PNS patients with high- or intermediate-risk or GAD65-antibodies without detectable tumor (PNS w/o T), and matched tumor patients without PNS (T w/o PNS) will be included in the study.
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
- •Patients with paraneoplastic neurological syndromes (PNS) and high- or intermediate-risk or GAD65-antibodies or
- •Patients with peripheral tumors without PNS
排除标准
- •Age below 18 years at the time of inclusion.
- •Any mental condition impairing the capacity to provide informed consent.
- •Presence of contraindications to DLA.
结局指标
主要结局
CTC detection
时间窗: Time of enrollment (BL)
Detection of circulating tumor cells (CTCs) in the peripheral blood
ctDNA detection
时间窗: Time of enrollment (BL)
Detection of circulating tumor DNA (ctDNA) in serum
次要结局
- CTC mutation profile(Time of CTC analysis (BL))
研究者
PD Dr. Nico Melzer
Chief Consultant Neurologist
Heinrich-Heine University, Duesseldorf