Tumor Rebiopsy During Progression Under Immunotherapy for Patients With Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Incidence of specific histomolecular resistance
研究概览
简要总结
The objective of the study aims to collect tumor tissue at the moment of progression under Immune checkpoint inhibitors (ICI) in biological resources center in Ambroise Paré hospital, in order to insure later study on molecular mechanism involving the progression of NSCLC and SCLC under ICI.
The further analysis of research will be performed in the EA 4340 unity, Biomarkers and Clinical Trials in cancerology and onco-hematology, UVSQ, University of Paris-Saclay.
详细描述
The study will consist of creation a tumor tissue bank, all sampling will be stored in the biological resources center of Ambroise Paré hospital.
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
- •Diagnosed NSCLC or SCLC;
- •Patient treated priorly by ICI and progressed under ICI;
- •Have provided written informed consent for the study;
- •Be >/= 18 years of age on day of signing informed consent.
排除标准
- •Patient under guardianship or curatorship;
- •Unable to provide written informed consent for the study;
- •Technical impossibility to carry out tissular rebiopsy under local anesthesia.
结局指标
主要结局
Incidence of specific histomolecular resistance
时间窗: At the end of study, up to 2 years
Banking of tumor samples at progression with immune checkpoint inhibitor (ICI) in lung cancer, to evaluate the incidence of specific histomolecular resistance mechanisms to ICI by immunohistochemistry and molecular testing.
次要结局
未报告次要终点