Analyzing Blood Samples for Advanced Lung Cancer Treatment
Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to TKI in Patients With Advanced NSCLC.
Recruiting
Observational Study
Non Small Cell Lung CancerStage IIIB Non-small Cell Lung CancerStage IIIC Non-Small Cell Lung CancerStage IV Non-small Cell Lung CancerTyrosine Kinase Inhibitors
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Study type
Observational
Participants needed
50 (estimated)
Sponsor
Gene Solutions · Industry
Who this trial is looking for
This trial is looking for patients with advanced non-small cell lung cancer who are starting treatment with a specific medication called Tyrosine kinase inhibitors. Participants will provide blood samples to help understand how their cancer responds to the treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with advanced non-small cell lung cancer.
I am eligible for Tyrosine kinase inhibitors.
I have a blood sample available.
I agree to follow the treatment protocol.
I consent to participate in the study.
You may not be able to join if
I have already started Tyrosine kinase inhibitors.
I have already started chemotherapy.
I have medical or psychiatric issues that affect my ability to follow the protocol.
I do not agree to participate in the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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
…
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.
Trial Locations
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City
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Status
Eligibility Criteria
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.
Excl…
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.
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