A Prospective Study Using Genomic Screening to Select Patients for Targeted Molecular Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Median progression free survival (PFS)
研究概览
简要总结
Patients with advanced solid tumors referred to the Phase 1 Unit are offered mapping of GA for identification of pts who could benefit from a personalized treatment.
详细描述
Two ultrasound-guided biopsies obtained to be stored in RNAlater® for DNA and RNA purification. A 3rd biopsy for histology is paraffin embedded. SNP-array (Affymetrix Cytoscan HD) from DNA (tumor) is performed to identify copy number changes. Whole exome sequencing (WES) from DNA (tumor and blood) will be performed using sequence capture, SureSelect v5 (Agilent) and Illumina HiSeq2500 to call tumor specific mutations. Expression levels of therapeutic targets are revealed by expression Array from tumor RNA. In addition to the expression array, RNA-seq (Nugens Ovation RNA-seq system v2) is performed to investigate whether chromosomal translocations were the reason for tumor specific expression of an oncogene. Results will be reviewed by a tumor board. Patients with specific genetic profiles that can be targeted with marketed drugs or drugs under development are offered such treatment. PFS from the treatment is compared to PFS of the most recent standard treatment (PFS ratio).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Solid tumor
- •No standard treatment option
- •Lesion assessable for biopsy
- •Measurable disease
- •Informed consent
排除标准
- •Life expectancy < 3 months
- •Bone marrow suppression
- •Abnormal renal or hepatic function
- •Serious concurrent medical conditions
研究组 & 干预措施
tumor biopsy
Tumor biopsy for targeted treatment according to molecular profile
干预措施: Tumor biopsy (Procedure)
结局指标
主要结局
Median progression free survival (PFS)
时间窗: Median time from date of randomization to date of progression or death, assessed up to 100 months
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
次要结局
未报告次要终点
研究者
Ulrik Lassen
MD, PH.D
Rigshospitalet, Denmark
