A Study of Molecular Residual, Dynamic Monitoring and Recurrence of Stage III Driver Mutated NSCLC (NCT06443684) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Study of Molecular Residual, Dynamic Monitoring and Recurrence of Stage III Driver Mutated NSCLC
China305 participantsStarted 2023-05-08
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is tracking something called 'molecular residual disease' or MRD in people with Stage III lung cancer who have a driver gene mutation — does my cancer have a driver mutation, and would knowing my MRD status actually change how my treatment is managed?
2Since this study is observational and focused on monitoring rather than testing a new treatment, what would detecting MRD-positive results early actually mean for my care — would it lead to a change in therapy, or is this primarily research data at this stage?
3The trial is no longer actively recruiting new patients — is there another similar study or monitoring program I could be considered for that tracks molecular residual disease in my situation?
4This study follows patients for 12 months looking at relapse events — given my current treatment plan, how would you use MRD monitoring results alongside standard imaging and checkups to guide decisions about my care?
5For someone with Stage III driver-mutated NSCLC like this study focuses on, are there targeted therapies or adjuvant treatments already proven to reduce relapse risk that I should be considering alongside or instead of enrolling in an observational study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation of MRD status in driver gene-positive NSCLC patients with 12-month relapse events
. 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