A Study of Molecular Residual, Dynamic Monitoring and Recurrence of Stage III Driver Mutated NSCLC
NCT ID: NCT06443684
Last Updated: 2025-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
305 participants
OBSERVATIONAL
2023-05-08
2026-03-31
Brief Summary
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1\) Whether MRD(Minimal residual disease) status can predict recurrence events in stage III driven-mutant NSCLC in advance
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Direct surgery
Stage III NSCLC eligible for direct surgery
Interventions:
Diagnostic Test: MRD（LC-10）include 10 lung cancer-related driver gene mutation site
MRD
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
MRD
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
MRD
MRD（LC-10）include 10 lung cancer-related driver gene mutation site
Interventions
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MRD
MRD（LC-10）include 10 lung cancer-related driver gene mutation site
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Shanghai Chest Hospital
OTHER
Responsible Party
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Lu Shun
Professor Chief of Shanghai Lung Cancer Center
Principal Investigators
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Shun Lu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Shanghai Chest Hospital
Locations
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First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Hunan Cancer Hospital
Changsha, Hunan, 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
Countries
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Central Contacts
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Facility Contacts
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Guojun Geng, M.D.
Role: primary
Yuan Qiu, M.D.
Role: primary
Yan Yu, M.D.
Role: primary
Wenxiang Wang, M.D.
Role: primary
Zhongmin Peng, M.D.
Role: primary
Di Ge, M.D.
Role: primary
Weihua Yang, M.D.
Role: primary
Junke Fu, M.D.
Role: primary
Jian Hu, M.D.
Role: primary
Qixun Chen, M.D.
Role: primary
Other Identifiers
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ADX-MRD-LC
Identifier Type: -
Identifier Source: org_study_id
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