Based on Plasma Exosomes Combined With Multi-omics Analysis to Reveal the Trajectory of Targeted Therapy Resistance and Novel Target Intervention Therapy in Patients With EGFR Mutation in Lung Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
The objective of this observational study is to explore the therapeutic trajectory of targeted therapy in lung adenocarcinoma patients with epidermal growth factor receptor (EGFR) mutations. The main objective is to identify potential biomarkers that can predict the efficacy of targeted therapy through plasma exosomes and to explore strategies to reverse drug resistance to targeted therapy. Biological specimens and medical imaging data will be collected from patients already receiving targeted therapy as a first-line treatment, and followed-up will be conducted to analyze prognosis based on different patterns.
详细描述
The medical imaging data will be collected retrospectively and prospectively, and the blood samples and tumor tissues will be collected prospectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological examination confirmed lung adenocarcinoma
- •No other type of tumor was present
- •Common sensitive EGFR (Ex19Del L858R or combined with other sites) mutations have been identified
- •Receive targeted therapy with or without chemotherapy as first-line treatment
- •≥ 18 years and ≤80 years old
排除标准
- •History of other malignant tumors
- •Irregular treatment or poor compliance
- •Incomplete clinical information or lost to follow-up
结局指标
主要结局
progression-free survival
时间窗: A two-year period after starting treatment (Regular follow-up every three months after receiving targeted therapy combined with or without chemotherapy as first-line treatment)
The time of disease progression is evaluated according to the Response Evaluation Criteria in Solid Tumors, version 1.1.
次要结局
- Overall survival(A three-year period after starting treatment (Regular follow-up every six months after receiving targeted therapy combined with or without chemotherapy as first-line treatment))
研究者
Yang Jin
deputy dean
Wuhan Union Hospital, China