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Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to TKI in Patients With Advanced NSCLC.

RECRUITINGSponsored by Gene Solutions
Actively Recruiting
SponsorGene Solutions
Started2023-12-04
Est. completion2025-11-01
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted

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.

Eligibility

Age: 18 Years – 80 YearsHealthy volunteers accepted
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.

Conditions7

CancerLung CancerNon Small Cell Lung CancerStage IIIB Non-small Cell Lung CancerStage IIIC Non-Small Cell Lung CancerStage IV Non-small Cell Lung CancerTyrosine Kinase Inhibitors

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