A Study Evaluating MRD Biomarker in Patients With Potentially Resectable Stage III 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
- 65
- 试验地点
- 1
- 主要终点
- Disease-free survival (RECIST)
研究概览
简要总结
Stratification of postoperative ctDNA status can effectively assess the risk of recurrence in patients. In addition, the multi-node dynamic monitoring of ctDNA is more effective in predicting the recurrence risk of patients. In this study, EGFR/ALK negative potentially resectable Stage III non-small cell lung cancer were enrolled. Baseline tissues, Peripheral blood samples of patients at baseline puncture tissue, after neoadjuvant therapy, after surgery (if any), after adjuvant therapy, and at multiple nodes during follow-up were collected for 1021-MRD analysis through tumor-informed personalized monitoring MRD test kit. This study aim to explore MRD biomarker in patients with potentially resectable stage III non-small cell lung cancer.
详细描述
In this prospective study, 65 patients with potentially operable non-small cell lung cancer without driving gene EGFR/ALK mutation in stage III were enrolled in this prospective study. peripheral blood samples from multiple nodes after neoadjuvant therapy, postoperative (if any), adjuvant therapy and follow-up were collected and analyzed by high-throughput sequencing in the target region. Patients were enrolled in the study for 1 year, followed up for 2 years, and the study lasted for 3 years. The patients were followed up for 2 years according to the standard diagnosis and treatment path, with a total of 9 times of follow-up, all of which were 3-month follow-up plan of the standard diagnosis and treatment path, and the follow-up examination was conducted in accordance with clinical standards.
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
- •Capable of giving signed informed consent, age ≥ 18 and ≤
- •patients with stage Ⅲ non-small cell lung cancer confirmed by histology or cytology have potential surgical opportunities.
- •No driving gene EGFR/ALK mutation.
- •the treatment process cooperated with the provision of clinicopathological and imaging data needed in the research process, followed up and collected the blood of the clinical efficacy evaluation nodes, and agreed to use the test data for follow-up research and product development.
排除标准
- •patients suffering from other malignant tumors.
- •patients change the treatment regimen before receiving the specified treatment or before the disease progresses.
- •Patients could not cooperate with the study for follow-up according to the defined clinical follow-up period;
- •Patients were unable to accept or provide imaging and other designated therapeutic evaluation means.
结局指标
主要结局
Disease-free survival (RECIST)
时间窗: follow-up time: 2 years
Disease-free survival (RECIST)： the survival time from operation or radiation to recurrence
次要结局
- OS(follow-up for 2 years)
- pCR rate of MRD-negative patient(2 years)
- The prediction of recurrence by positive MRD(follow-up for 2 years)
- 2-year DFS of ctDNA-negative patients in operation group / inoperable group(follow-up time: 2 years)
- Negative MRD rate in pCR patients(follow-up time: 2 years)