KEAPnes: Transcriptional Framework for the Molecular Diagnosis of Response to Immunotherapy in Lung Cancer With Agnostic Potential
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Innovative molecular tool
研究概览
简要总结
Through genomic and transcriptomic sequencing techniques (whole exome sequencing, WES; whole transcriptome sequencing, WTS) patients with enrichment for KEAPness and specific gene interactions associated with it.
详细描述
Retrospective-prospective, non-pharmacological, biological, multicenter observational study, for which the collection and use of tissue samples from patients suffering from NSCLC and/or other tumor types. Through genomic and transcriptomic sequencing techniques (whole exome sequencing, WES; whole transcriptome sequencing, WTS) patients with enrichment for KEAPness and specific gene interactions associated with it. Subsequently, through the same techniques, applied to different tumor regions taken from operating site it will be possible to identify the evolution of the tumor at a spatio-temporal level and the immune subtype associated with the presence/absence of KEAPness. Finally, cell lines will be used to recapitulate what was observed in the patient and per-patient cohorts identify new pharmacological vulnerabilities associated with the characteristics of KEAPness.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Innovative molecular tool
时间窗: 24 months
To generate an innovative molecular tool for prediction DNA/RNA will be extracted from 5μm FFPE tissue sections using the AllPrep DNA/RNA FFPE kit (Qiagen). The quality of the RNA will be evaluated with the Bioanalyzer, the integrity of genomic DNA through the Agilent NGS FFPE qPCR QC Kit (Agilent). The libraries for RNA-Seq will be prepared using the RNA TruSeq Exome Kit (Illumina). The quality of the libraries resulting will be checked using Bioanalyzer (high sensitivity DNA kit). The intermediate library before exon enrichment will be quantified with Qubit, the final library with qPCR. The samples will be sequenced in paired-end mode, sequencing 76 bp on each side. The Exome DNA sequencing will be performed using SureSelectXT Low Input Kit reagents for the initial preparation of the library followed by enrichment with Clinical Research Exome Kit (Agilent).
次要结局
- Tracing the evolutionary path(24 months)
- Identification of therapeutic vulnerabilities specific(24 months)