Study on Fluids Associated to Lung Cancer, of the Ectopic Expression of Cancer Testis Gene and Mutation as Diagnostics and Prognosis Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Quantification of : DNA
研究概览
简要总结
The diagnosis of lung cancer is the first cause of cancer deaths for man and woman. It requires invasive procedures (at least endoscopy, transthoracic puncture, or surgery).
This study is about the set up of an innovative test for lung cancer prognosis, based on biopsies and surgical material : LungCancerTest, with the creation of a start-up in progress.
The main goal of this study is to approve the diagnostic value of the molecular signature of the 26 genes (LungCancerTest) revealed in blood and respiratory fluids among patients with lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 lung cancer in stage 1-2, lung cancer of all histology kind eligible for surgery (Group 1).
- •Patients with lung cancer in stage 3-4 (no adenocarcinoma or squamous) receiving classical or targeted chemotherapy on genetic anomalies (Group 2).
- •Control patients : carriers of non-cancerous radiological anomalies : benign nodules, cicatricial lesions, infectious or inflammatory, paired with the two other groups by age, sex or tobacco (Group 3).
- •Adults patients : over 18 years.
- •Persons affiliated to national social security.
- •Free signed consent.
排除标准
- •Persons referred to in articles L1121-5 to L1121-8 of CSP ( protected people) : pregnants, parturients or breastfeeding women, person deprived of liberty by judicial or administrative decision, person under legal protection.
结局指标
主要结局
Quantification of : DNA
时间窗: Half a day
From plasma or respiratory fluids, with Qiagen QIAamp MinElute Virus Spin kit. Picogreen technique (fluorimétrie) with the device Qubit 2.0 Characterization of DNA by migration on revealed agarose gel in presence of ethidium bromide Study of DNA (mutation, reassortment) with New Generation Sequencing materiel.
Quantification of : RNA
时间窗: Half a day
From plasma or respiratory fluids, with Qiagen QIAamp MinElute Virus Spin kit. Picogreen technique (fluorimétrie) with the device Qubit 2.0 Characterization of RNA with an Agilent chip Study of RNA (LungCancerTest) with PCR-Array prototype to show the expression of the molecular signature (Cancer Testis genes).
次要结局
未报告次要终点