Development and Validation of Non-Invasive Monitoring Techniques for Postoperative Recurrence and Novel Adjuvant Therapeutic Strategies in Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Two-year recurrence-free survival rate
研究概览
简要总结
The goal of this study is to develop new techniques for minimal residual disease(MRD) monitoring and to confirm the efficacy and safety of MRD-guided postoperative management for early stage non-small cell lung cancer. The main questions this study aims to answer are:
- How to develop multi-omics-based high-sensitivity detection methods to accurately capture MRD and monitor postoperative recurrence in lung cancer?
- Is adaptive treatment guided by ctDNA-MRD for lung cancer patients superior to traditional clinical management and effectively improves survival?
- Do heterogeneous patient populations (grouped by stages, histopathological subtypes, driver mutations, and treatment histories) show differences in effects under ctDNA-MRD guided postoperative management strategies?
详细描述
Approximately 30% of early-stage lung cancer patients experience recurrence after curative surgery. However, the clinical utility of routine chest CT surveillance remains limited. Emerging evidence has demonstrated that liquid biopsy-based minimal residual disease (MRD) detection may serve as a more sensitive monitoring strategy. Longitudinal ctDNA dynamics analysis further enables real-time assessment of tumor progression and early detection of molecular relapse.
This study aims to develop a novel multidimensional approach for non-invasive postoperative recurrence monitoring in lung cancer and establish an MRD-guided adjuvant therapy model to optimize precision treatment and MRD-stratified follow-up protocols for lung cancer patients. This study will evaluate the sensitivity and specificity of novel monitoring methods and further compare emerging non-invasive recurrence monitoring approaches with conventional ctDNA-based techniques, driving continuous advancements in lung cancer research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Non-small cell lung cancer with stage IA-IIIA (8th edition TNM classification) planning to undergo curative surgery or to undergo neoadjuvant therapy
- •Solid nodules >1 cm or ground-glass nodules >1.5 cm on imaging
- •No history of malignancies other than non-small cell lung cancer in the past 5 years
- •Specimens are well preserved and imaging documents are accessible.
排除标准
- •Age<18 years old
- •Non-small cell lung cancer with pathologic stage IIIB-IV (8th edition TNM classification)
- •Pathology results confirmed not to be non-small cell lung cancer
- •History of malignancies other than non-small cell lung cancer in the past 5 years
研究组 & 干预措施
adaptive postoperative management group
For those who don't receive neoadjuvant therapy, if the MRD testing results after surgery keep negative, postoperative adjuvant therapy will be waived.
For those who receive neoadjuvant therapy, if the efficacy reaches pathological complete response(pCR) and MRD testing results keep negative, postoperative adjuvant therapy will be waived.
Otherwise, participants will receive a customized treatment plan based on Multi-disciplinary Treatment (MDT).
干预措施: Adaptive postoperative management based on minimal residual disease (Other)
standard clinical postoperative management group
These participants will receive standard postoperative adjuvant therapy and routine follow-up.
结局指标
主要结局
Two-year recurrence-free survival rate
时间窗: Time from curative surgery to confirmation of clinical progression (recurrence or metastasis) within two years.
The difference in the proportion of patients with (suspected) relapse or metastasis between the intervention group and the control group within two years.
次要结局
- Overall survival(Time from curative surgery to confirmation of death (any cause)，assessed up to 60 months.)
- Incremental cost effectiveness ratio(24 months after surgery)
- Timely diagnosis rate by the novel MRD monitoring technique(two years)
- Sensitivity of the novel MRD monitoring approach(two years)
研究者
Chen KeZhong
Professor
Peking University People's Hospital