Radiomics and Radiogenomics of Non-small Cell Lung Cancer: Relationships of Radiomic Signature With Gene Driver Mutations and Implications for Emerging Therapies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Evaluation of the association between the status of Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), Kirsten Rat Sarcoma Virus (KRAS) and nodal status
研究概览
简要总结
In this study, the radiomic characteristics and a broad range of genetic aberrations in lung adenocarcinomas will be evaluated. Investigators will assess changes in the radiomic and genetic profiles during targeted therapies in a subset of patients harboring treatable mutations. Patients undergoing targeted therapies will also be evaluated for variations in genomic profile and radiomic signature during follow-up
详细描述
Non-small cell lung cancers (NSCLC) are the first cause of cancer-related deaths.
Recent guidelines suggest the key role of a wide molecular profile because knowledge of the tumor genotype can enable patients with NSCLC to be treated with targeted therapies.
In this study, a first group of patients with lung adenocarcinoma (study group), tested for the presence of genetic alterations in EGFR, ALK, and KRAS, and with available Computer Tomography (CT) scans, will be evaluated to create a radiomic signature and assess its association with mutational status and prognosis.
Then, a second group of patients (validation group) will be enrolled to validate the radiomic signature and the status of the genetic alterations and their association with prognosis. Radiomic signature and liquid biopsies will be evaluated in patients positive for genetic alterations at each follow-up step to verify their association with prognosis and response to targeted therapies.
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
- •patients with diagnosis of NSCLC
- •patients candidates for mutational status assessment
排除标准
- •- patients with age <18 years
研究组 & 干预措施
Radiomic signature
Assessment of radiomic signature and tumor genetic profile at baseline
干预措施: Radiomic signature (Diagnostic Test)
结局指标
主要结局
Evaluation of the association between the status of Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), Kirsten Rat Sarcoma Virus (KRAS) and nodal status
时间窗: 1 month
The status of EGFR, ALK, KRAS will be validated for its association with nodal status at surgery
Evaluation of the association between the status of EGFR, ALK, KRAS and disease free survival (DFS)
时间窗: 5 years
Number of patiens with EGFR, ALK, KRAS mutations with an oncological event (local or distant) during follow up
Evaluation of the association between the status of EGFR, ALK, KRAS and overall survival (OS)
时间窗: 5 years
Number of patiens with EGFR, ALK, KRAS mutations alive at five years
次要结局
未报告次要终点