Cancer Panel From Blood of Lung Cancer Patients (CAPABLE)

January 18, 2019 updated by: Jong-Seok Lee, Seoul National University Hospital

Clinical Validity of Oncogenic Driver Genes Detected From Circulating Tumor DNA in Blood of Lung Cancer Patients

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seongnam, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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 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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance rate
Time Frame: an average of one year
Concordance rate of genomic change between tumor tissue (FFPE) and ctDNA
an average of one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: an average of one year
To evaluate prognostic role of ctDNA concentration in NSCLC
an average of one year
Frequency of actionable genomic change
Time Frame: an average of one year
To determine the frequency of actionable oncogenic genes in NSCLC
an average of one year
Overall survival by treatment
Time Frame: an average of one year
To evaluate the survival of patients treated with genotype-directed therapy in daily practice
an average of one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

MACROGEN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2017

Primary Completion (Anticipated)

March 10, 2019

Study Completion (Anticipated)

March 10, 2020

Study Registration Dates

First Submitted

July 28, 2017

First Submitted That Met QC Criteria

July 28, 2017

First Posted (Actual)

August 1, 2017

Study Record Updates

Last Update Posted (Actual)

January 22, 2019

Last Update Submitted That Met QC Criteria

January 18, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH-17-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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