Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT06167460

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

Led by Gene Solutions · Updated on 2025-07-16

50

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with advanced non-small cell lung cancer and planned for first or second line TKI treatment; TKI combined with chemotherapy is allowed
  • Available formalin-fixed paraffin-embedded (FFPE) or fine needle aspiration (FNA) tumor sample
  • Able to comply with the treatment protocol
  • Provided consent to participate in the study
Not Eligible

You will not qualify if you...

  • Already started Tyrosine kinase inhibitor treatment before enrollment
  • Already started chemotherapy before enrollment
  • Medical or psychiatric conditions or occupational responsibilities that may prevent following the protocol
  • Did not agree to participate in the study

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Trial Site Locations

Total: 1 location

1

Medical Genetics Institute

Ho Chi Minh City, Vietnam

Actively Recruiting

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Research Team

L

Lan NL Tu, PhD

CONTACT

V

VAN T Phan, MSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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