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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct surgery | Stage III NSCLC eligible for direct surgery Interventions: Diagnostic Test: MRD(LC-10)include 10 lung cancer-related driver gene mutation site |
| |
| 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 |
| |
| Chemoradiotherapy | Unresectable Stage III NSCLC eligible for Chemoradiotherapy. Interventions: Diagnostic Test: MRD(LC-10)include 10 lung cancer-related driver gene mutation site |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRD | Diagnostic Test | MRD(LC-10)include 10 lung cancer-related driver gene mutation site |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of MRD status in driver gene-positive NSCLC patients with 12-month relapse events | 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. | 2022.12--2025.03 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of MRD status in driver gene-positive NSCLC patients with RFS | 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. | 2022.12--2025.03 |
| Correlation of MRD status in driver gene-positive NSCLC patients with OS |
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Inclusion Criteria:
Exclusion Criteria:
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305 The main research purpose of this project is to associate the MRD status of driver gene positive patients with 12 months of recurrent events. The follow-up is 2 years, so according to the number of patients with stage IIIA NSCLC in each center, and the patient enrollment is planned within 1 year. A total of 305 stage III NSCLC patients were collected
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| Name | Affiliation | Role |
|---|---|---|
| Shun Lu, M.D. | Shanghai Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of USTC / Anhui Provincial Hospital | Hefei | Anhui | 230000 | China | ||
| First Affiliated Hospital of Xiamen University |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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Full blood samples processed into plasma, buffy coat,and serum Formalin-fixed paraffin-embedded tumor tissue
Patients are defined as MRD positive if the NGS method detects lung cancer driver gene positivity in the peripheral blood post-surgery. |
| 2022.12--2025.03 |
| Correlation of MRD status in driver gene-positive NSCLC patients with 24-month relapse events | 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. | 2022.12--2025.03 |
| Xiamen |
| Fujian |
| China |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China |
| Affiliated Cancer Hospital of Harbin Medical University | Harbin | Heilongjiang | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450000 | China |
| Hunan Cancer Hospital | Changsha | Hunan | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | 250000 | China |
| Shandong Provincial Hospital | Jinan | Shandong | China |
| Shanghai Chest hospital | Shanghai | Shanghai Municipality | China |
| Zhongshan Hospital Affiliated to Fudan University | Shanghai | Shanghai Municipality | China |
| Shanxi Cancer Hospital | Taiyuan | Shanxi | China |
| The First Affiliated Hospital of Xi 'an Jiaotong University | Xi’an | Shanxi | China |
| The First Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | China |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |