Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to Tyrosine Kinase Inhibitors in Patients With Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Relationship between ctDNA dynamics and clinical response to TKI
研究概览
简要总结
This is an observational study, aiming to investigate whether the ctDNA dynamics analyzed by the K-TrackTM assay could predict early response to Tyrosine kinase inhibitors (TKIs) in patients with advanced non-small cell lung cancer (NSCLC).
- Determine relationship between ctDNA dynamics and clinical response to TKI,
- No response/progressive disease = ctDNA levels increase from baseline
- Partial response/stable disease = ctDNA levels decrease from baseline
- Complete response = ctDNA clearance.
- Compare and combine ctDNA dynamics and RECIST1.1 to predict clinical response.
- Determine relationship between ctDNA dynamics and progression free survival, overall survival.
详细描述
This study is recruiting female and male patients, aged 18 and older:
- Who are diagnosed with advanced non-small cell lung cancer and indicated for TKI (first or second line). TKI combined with chemotherapy is allowed,
- Who have not started TKI / chemotherapy before enrollment,
- Who have no medical or psychiatric conditions or occupational responsibilities that may preclude compliance with the protocol,
- FFPE/FNA sample is available,
- Compliant with treatment protocol,
- Patients consented to participate in the study. As part of the protocol, demographic data, medical and family history, and any relevant prior concomitant medication data will be recorded during follow-up visits. All patients are to be followed for 2 years from enrollment, with CT scan imaging measured every clinical visit for 24 months.
Sample collection:
- 10 mL of peripheral blood (in Streck tubes) is collected for ctDNA analysis at 8 time points: pre-treatment (<10 days before TKI), during TKI every 3 months until 21 months.
- 6-8 sections of formalin-fixed paraffin-embedded (FFPE) tumor samples before TKI/chemotherapy treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients are diagnosed with advanced non-small cell lung cancer and indicated for TKI (first or second line). TKI combined with chemotherapy is allowed.
- •FFPE/FNA sample is available.
- •Compliant with treatment protocol.
- •Patients consented to participate in the study.
排除标准
- •Patients already started TKI before enrollment.
- •Patients already started chemotherapy before enrollment.
- •Medical or psychiatric conditions or occupational responsibilities that may preclude compliance with the protocol.
- •Patients did not agree to participate in the studies.
结局指标
主要结局
Relationship between ctDNA dynamics and clinical response to TKI
时间窗: 24 months following up.
* No response/progressive disease = ctDNA levels increase from baseline * Partial response/stable disease = ctDNA levels decrease from baseline * Complete response = ctDNA clearance.
To investigate the relationship between ctDNA dynamics and progression free survival, overall survival.
时间窗: 24 months following up.
* Correlation between ctDNA dynamics and PFS * Correlation between ctDNA dynamics and OS.
To compare and combine ctDNA dynamics and RECIST1.1 to predict clinical response.
时间窗: 24 months following up.
* Correlation between ctDNA dynamics and clinical response * Correlation between RECIST1.1 and clinical response * Combination of ctDNA dynamics and RECIST v1.1 in the prognosis of clinical response.
次要结局
未报告次要终点