Cancer Panel From Blood of Lung Cancer Patients

Non Small Cell Lung Cancer Metastatic Clinical Trial

— CAPABLE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03235765
• Other study ID #: SNUBH-17-01
• Status: Active, not recruiting
• Start date: March 10, 2017
• Est. completion date: March 10, 2020

Study information

• Verified date: January 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: March 10, 2020
• Est. primary completion date: March 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer Metastatic
• Non Small Cell Lung Cancer Recurrent

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	MACROGEN

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance rate	Concordance rate of genomic change between tumor tissue (FFPE) and ctDNA	an average of one year
Secondary	Overall survival	To evaluate prognostic role of ctDNA concentration in NSCLC	an average of one year
Secondary	Frequency of actionable genomic change	To determine the frequency of actionable oncogenic genes in NSCLC	an average of one year
Secondary	Overall survival by treatment	To evaluate the survival of patients treated with genotype-directed therapy in daily practice	an average of one year