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临床试验/NCT06443684
NCT06443684进行中(未招募)不适用

Prospective, Observational Study of Molecular Residual, Dynamic Monitoring and Recurrence of Stage III Driver Mutated NSCLC

Shanghai Chest Hospital14 个研究点 分布在 1 个国家目标入组 305 人开始时间: 2023年5月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
305
试验地点
14
主要终点
Correlation of MRD status in driver gene-positive NSCLC patients with 12-month relapse events

研究概览

简要总结

The goal of this prospective, observational study is to explore the value of dynamic monitoring of minimal residual lesions in driver mutated stage III NSCLC for disease recurrence and prognosis assessment. The main question it aims to answer is:

1) Whether MRD(Minimal residual disease) status can predict recurrence events in stage III driven-mutant NSCLC in advance

详细描述

Non-small cell lung cancer in stage III (IIIa, IIIIb, IIIc) has a low survival rate, and the 5-year survival rate of stage III patients is less than 30%. In clinical studies of non-small cell lung cancer operable stage III driver gene mutations, postoperative targeted adjuvant therapy improves patient survival relative to postoperative chemotherapy.

The tumor patients still have residual malignant tumor cells in vivo during or after treatment, and minimal residual foci are released during cell necrosis or apoptosis. Early the domestic large lung cancer MRD((Minimal residual disease)) prospective research results, for the first time through the dynamic monitoring of MRD high negative predictive value defined the potential cure population, found that postoperative MRD negative population could not benefit from adjuvant therapy, clarify the existence of preoperative Non-shedding tumor does not affect postoperative MRD monitoring, and exploring the stage II / III MRD turn high risk of postoperative lung cancer. Therefore, for nearly 70% of patients with driver gene-positive non-small-cell lung cancer, detecting clear driver gene mutations in the peripheral blood is expected to stratify the risk of recurrence/progression.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with stage III non-small cell lung cancer were confirmed by imaging and histological biopsy
  • •ECOG PS:0-1
  • •Tumor molecular testing by EBUS or biopsy confirmed positive for one or more of the following driver genes:EGFR\ALK\ROS1\RET\KRAS\PIK3CA\BRAF\HER2\MET
  • •Patients who met and agreed to surgery or radical chemoradiotherapy, and the remaining samples after cutting tissue sections did not affect the possible further clinical treatment of the subject
  • •Provide 20 mL peripheral blood samples periodically
  • •The subjects volunteered to join the study, and signed the informed consent form, with good compliance, and actively cooperated with the hospital for routine clinical diagnosis and treatment follow-up

排除标准

  • •Patients with other malignancies within 5 years
  • •According to the investigator, the patient also had other diseases that may affect the follow-up and short-term survival
  • •The subject had other factors that may lead to the termination of the study, such as other serious diseases (including mental illness), serious laboratory abnormalities, and family or social factors that affected the safety of the subject, or the collection of data and samples

研究组 & 干预措施

Chemoradiotherapy

Unresectable Stage III NSCLC eligible for Chemoradiotherapy.

Interventions:

Diagnostic Test: MRD(LC-10)include 10 lung cancer-related driver gene mutation site

干预措施: MRD (Diagnostic Test)

Direct surgery

Stage III NSCLC eligible for direct surgery

Interventions:

Diagnostic Test: MRD(LC-10)include 10 lung cancer-related driver gene mutation site

干预措施: MRD (Diagnostic Test)

Neoadjuvant and surgery

Stage III NSCLC eligible for neoadjuvant therapy followed by surgery

Interventions:

Diagnostic Test: MRD(LC-10)include 10 lung cancer-related driver gene mutation site

干预措施: MRD (Diagnostic Test)

结局指标

主要结局

Correlation of MRD status in driver gene-positive NSCLC patients with 12-month relapse events

时间窗: 2022.12--2025.03

Patients are defined as MRD positive if lung cancer driver genes are detected in peripheral blood post-surgery using NGS methods, and radiological recurrence is based on RECIST 1.1 criteria.

次要结局

  • Correlation of MRD status in driver gene-positive NSCLC patients with OS(2022.12--2025.03)
  • Correlation of MRD status in driver gene-positive NSCLC patients with RFS(2022.12--2025.03)
  • Correlation of MRD status in driver gene-positive NSCLC patients with 24-month relapse events(2022.12--2025.03)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lu Shun

Professor Chief of Shanghai Lung Cancer Center

Shanghai Chest Hospital

研究点 (14)

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