Cancer Panel From Blood of Lung Cancer Patients

Seoul National University Hospital200 enrolled

Overview

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).

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Non Small Cell Lung Cancer Metastatic Non Small Cell Lung Cancer Recurrent

Interventions

MACROGEN Pan Cancer Panel (Tier 2)DIAGNOSTIC_TEST

This study will utilize a MACROGEN Pan Cancer Panel (Tier 2), which is a hybrid capture-based NGS assay interrogating the coding regions of 170 cancer-related genes.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Bundang Hospital

Seongnam, South Korea

Outcomes

Primary Outcomes

Concordance rate

Concordance rate of genomic change between tumor tissue (FFPE) and ctDNA

Time frame: an average of one year

Secondary Outcomes

Overall survival

To evaluate prognostic role of ctDNA concentration in NSCLC

Time frame: an average of one year

Frequency of actionable genomic change

To determine the frequency of actionable oncogenic genes in NSCLC

Time frame: an average of one year

Overall survival by treatment

To evaluate the survival of patients treated with genotype-directed therapy in daily practice

Time frame: an average of one year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.