MRD: MRD(LC-10)include 10 lung cancer-related driver gene mutation site
Study summary
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Patients with stage III non-small cell lung cancer were confirmed by imaging and histological biopsy
2. Age≥ 18
3. ECOG PS:0-1
4. 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
5. 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
6. Provide 20 mL peripheral blood samples periodically
7. 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
Exclusion Criteria:
1. Patients with other malignancies within 5 years
2. According to the investigator, the patient also had other diseases that may affect the follow-up and short-term survival
3. 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
Primary outcome measure(s)
Correlation of MRD status in driver gene-positive NSCLC patients with 12-month relapse events — 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.
Trial sites (14)
Facility
City
Region
Status
The First Affiliated Hospital of USTC / Anhui Provincial Hospital
Hefei
Anhui
First Affiliated Hospital of Xiamen University
Xiamen
Fujian
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
Guangdong
Affiliated Cancer Hospital of Harbin Medical University
Harbin
Heilongjiang
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
Hunan Cancer Hospital
Changsha
Hunan
Qilu Hospital of Shandong University
Jinan
Shandong
Shandong Provincial Hospital
Jinan
Shandong
Shanghai Chest hospital
Shanghai
Shanghai Municipality
Zhongshan Hospital Affiliated to Fudan University
Shanghai
Shanghai Municipality
Shanxi Cancer Hospital
Taiyuan
Shanxi
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi’an
Shanxi
The First Affiliated Hospital of Zhejiang University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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