Official Title
Clinical Validity of Oncogenic Driver Genes Detected From Circulating Tumor DNA in Blood of Lung Cancer Patients
Brief Title
Cancer Panel From Blood of Lung Cancer Patients
Protocol ID
NCT03235765
Lead Sponsor
Seoul National University Hospital
Brief Summary
Molecular profiling of lung cancers using circulating tumor DNA (ctDNA) in the blood of
patients is rapidly becoming established as a useful source of information to aid
clinical decision-making. This study is aimed to to compare concordance rate between
tissue based cancer panel analysis and blood based cancer panel analysis in lung cancer
patients (both by NGS technique).
Detailed Description
This study is comprised of two cohorts as below:
Cohort A: inoperable, untreated, non-small cell lung cancer patients
Cohort B: non-small cell lung cancer patients who are in the treatment with targeted
agents including immune checkpoint inhibitors
Study Period
-
Enrollment Count
200 participants
Eligibility Criteria
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures, sampling, and
analyses
- Pathologically confirmed non-small cell lung cancer
- Male or female, aged at least 20 years
- Matches one of two criteria :
1. Cohort A: Patients who are diagnosed with metastatic/recurrent non-small cell
lung cancer and planned to receive first line chemotherapy
2. Cohort B: Patients with recurrent/metastatic non-small cell lung cancer who
have been receiving molecular targeted therapy, including immune checkpoint
inhibitor, and have tumor shrinkage with the agent.
Exclusion Criteria:
- Any concurrent and/or other active malignancy that has required treatment within 3
years
- Patients with mixed small cell histology
- Life expectancy less than 3 months
- Insufficient tissue for NGS test
Filters
Non Small Cell Lung Cancer Metastatic
Non Small Cell Lung Cancer Recurrent
UNKNOWN
ADULT
OLDER_ADULT