We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cancer Panel From Blood of Lung Cancer Patients (CAPABLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03235765
Recruitment Status : Unknown
Verified January 2019 by Jong-Seok Lee, Seoul National University Bundang Hospital.
Recruitment status was:  Active, not recruiting
First Posted : August 1, 2017
Last Update Posted : January 22, 2019
Sponsor:
Collaborator:
MACROGEN
Information provided by (Responsible Party):
Jong-Seok Lee, Seoul National University Bundang Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Metastatic Non Small Cell Lung Cancer Recurrent Diagnostic Test: MACROGEN Pan Cancer Panel (Tier 2)

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Clinical Validity of Oncogenic Driver Genes Detected From Circulating Tumor DNA in Blood of Lung Cancer Patients
Actual Study Start Date : March 10, 2017
Estimated Primary Completion Date : March 10, 2019
Estimated Study Completion Date : March 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Concordance rate [ Time Frame: an average of one year ]
    Concordance rate of genomic change between tumor tissue (FFPE) and ctDNA


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: an average of one year ]
    To evaluate prognostic role of ctDNA concentration in NSCLC

  2. Frequency of actionable genomic change [ Time Frame: an average of one year ]
    To determine the frequency of actionable oncogenic genes in NSCLC

  3. 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


Biospecimen Retention:   Samples With DNA
Cancer panel analysis will be done with patients tumro tissue and ctDNA

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235765


Locations
Layout table for location information
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
MACROGEN
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Jong-Seok Lee, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03235765    
Other Study ID Numbers: SNUBH-17-01
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: January 22, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jong-Seok Lee, Seoul National University Bundang Hospital:
NSCLC
Cancer panel
NGS
Actionable mutation
Immune checkpoint inhibitor
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms