RecruitingNCT06443684
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
Sponsor
Shanghai Chest Hospital
Enrollment
305 participants
Start Date
May 8, 2023
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria7
- 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
Exclusion Criteria3
- 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
Interventions
DIAGNOSTIC_TESTMRD
MRD（LC-10）include 10 lung cancer-related driver gene mutation site
Locations(11)
View Full Details on ClinicalTrials.gov
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NCT06443684
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