A Study of Molecular Residual, Dynamic Monitoring and Recurrence of Stage III Driver Mutated NSCLC
Prospective, Observational Study of Molecular Residual, Dynamic Monitoring and Recurrence of Stage III Driver Mutated NSCLC
1 other identifier
observational
305
1 country
11
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2023
Typical duration for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 8, 2023
CompletedFirst Submitted
Initial submission to the registry
May 30, 2024
CompletedFirst Posted
Study publicly available on registry
June 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedJanuary 7, 2025
January 1, 2025
1.9 years
May 30, 2024
January 5, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
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 OS
2022.12--2025.03
Correlation of MRD status in driver gene-positive NSCLC patients with 24-month relapse events
2022.12--2025.03
Study Arms (3)
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
Interventions
MRD（LC-10）include 10 lung cancer-related driver gene mutation site
Eligibility Criteria
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
You may qualify if:
- Patients with stage III non-small cell lung cancer were confirmed by imaging and histological biopsy
- Age≥ 18
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
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
Biospecimen
Full blood samples processed into plasma, buffy coat,and serum Formalin-fixed paraffin-embedded tumor tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shun Lu, M.D.
Shanghai Chest Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Chief of Shanghai Lung Cancer Center
Study Record Dates
First Submitted
May 30, 2024
First Posted
June 5, 2024
Study Start
May 8, 2023
Primary Completion
March 31, 2025
Study Completion
March 31, 2026
Last Updated
January 7, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share