Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to TKI in Patients Wit… (NCT06167460) | Clinical Trial Compass
RecruitingNot Applicable
Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to TKI in Patients With Advanced NSCLC.
Vietnam50 participantsStarted 2023-12-04
Plain-language summary
This is an observational study, aiming to investigate whether the ctDNA dynamics analyzed by the K-TrackTM assay could predict early response to Tyrosine kinase inhibitors (TKIs) in patients with advanced non-small cell lung cancer (NSCLC).
1. Determine relationship between ctDNA dynamics and clinical response to TKI,
* No response/progressive disease = ctDNA levels increase from baseline
* Partial response/stable disease = ctDNA levels decrease from baseline
* Complete response = ctDNA clearance.
2. Compare and combine ctDNA dynamics and RECIST1.1 to predict clinical response.
3. Determine relationship between ctDNA dynamics and progression free survival, overall survival.
Who can participate
Age range
18 Years – 80 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 are diagnosed with advanced non-small cell lung cancer and indicated for TKI (first or second line). TKI combined with chemotherapy is allowed.
* FFPE/FNA sample is available.
* Compliant with treatment protocol.
* Patients consented to participate in the study.
Exclusion Criteria:
* Patients already started TKI before enrollment.
* Patients already started chemotherapy before enrollment.
* Medical or psychiatric conditions or occupational responsibilities that may preclude compliance with the protocol.
* Patients did not agree to participate in the studies.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Relationship between ctDNA dynamics and clinical response to TKI
Timeframe: 24 months following up.
2
To compare and combine ctDNA dynamics and RECIST1.1 to predict clinical response.
Timeframe: 24 months following up.
3
To investigate the relationship between ctDNA dynamics and progression free survival, overall survival.