Cancer Panel From Blood of Lung Cancer Patients

NCT03235765 | Unknown

• 1 other identifier: SNUBH-17-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

NSCLC; Cancer panel; NGS; Actionable mutation; Immune checkpoint inhibitor

Outcome Measures

Primary Outcomes (1)

• Concordance rate

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

  an average of one year

Secondary Outcomes (3)

• Overall survival

  an average of one year

• Frequency of actionable genomic change

  an average of one year

• Overall survival by treatment

  an average of one year

Study Arms (2)

Cohort A

Patients who are diagnosed with metastatic/recurrent non-small cell lung cancer and planned to receive first line chemotherapy

Diagnostic Test: MACROGEN Pan Cancer Panel (Tier 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.

Diagnostic Test: MACROGEN Pan Cancer Panel (Tier 2)

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.

Cohort A; Cohort B

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inoperable non-small cell lung cancer with two cohorts as below: 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.

You may qualify if:

• 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 :
• Cohort A: Patients who are diagnosed with metastatic/recurrent non-small cell lung cancer and planned to receive first line chemotherapy
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• MACROGEN: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, 463-707, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cancer panel analysis will be done with patients tumro tissue and ctDNA

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 1, 2017
• Study Start: March 10, 2017
• Primary Completion: March 10, 2019
• Study Completion: March 10, 2020
• Last Updated: January 22, 2019

Record last verified: 2019-01

Locations

KR (1)