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NCT06167460Recruiting

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

Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to Tyrosine Kinase Inhibitors in Patients With Advanced Non-small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 16 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
50 (estimated)
First submitted
21 Nov 2023
Start date
4 Dec 2023
Primary completion date
1 Nov 2025
Lead sponsor
Gene Solutions
Diseases
Lung cancer
NCT number
NCT06167460

What you commit to

  • Study type: Observational
  • Planned participants: 50
  • From 4 Dec 2023 to the primary completion date, 1 Nov 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients already started chemotherapy before enrollment.

Other illness

  • Medical or psychiatric conditions or occupational responsibilities that may preclude compliance with the protocol.

Other

  • Patients already started TKI before enrollment.
  • Patients did not agree to participate in the studies.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical Genetics Institute
Coordinator of this site? Confirm its status
Ho Chi Minh CityVietnamRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.