Prospective Observational Study of a Precision Medicine Approach in Patients With Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Frequency of personalized treatment initiation
研究概览
简要总结
Prospective observational study of a precision medicine approach in patients with advanced cancer. In this registrational study, patients with advanced cancer undergoing extensive molecular sequencing within the precision oncology program of Charité University Medicine, Berlin will be registered and followed to assess the efficacy of the program and assess the clinical relevance and frequency of molecular alterations, individualized therapies and novel molecular analysis tools.
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
- •advanced cancer
- •ability to give written informed consent
- •performance status allows initiation of a potential targeted treatment after molecular analysis
- •molecular analysis has been done or planned
排除标准
- •unable to give written informed consent
结局指标
主要结局
Frequency of personalized treatment initiation
时间窗: At 1 year from date of study inclusion
Frequency of personalized treatment initiation
Frequency of molecularly stratified treatment options
时间窗: At 1 year from date of study inclusion
Number of molecularly stratified treatment options per patient
次要结局
- Progression free survival(Assessed up to 100 months)
- PFS-ratio(Assessed up to 100 months)
- frequency of re-diagnosis(At 1 year after study inclusion)
- frequency of recommendation of genetic counselling(At 1 year after study inclusion)
- frequency of pharmacogenomic findings(At 1 year after study inclusion)
- objective response rate(1 year after study inclusion)
- frequency of interventional study inclusion(At 1 year after study inclusion)
- overall survival(Assessed up to 100 months)
- Evidence level of molecularly stratified treatment options(At 1 year from study inclusion)
- frequency and type of resistance mutations(At 1 year after study inclusion)
研究者
Damian Rieke
Speaker, Platform for personalized cancer therapy at Charité Comprehensive Cancer Center, Principal Investigator, Medical Doctor
Charite University, Berlin, Germany