Cancer Panel From Blood of Lung Cancer Patients

NCT ID: NCT03235765

Last Updated: 2019-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-10

Study Completion Date

2020-03-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort A

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

MACROGEN Pan Cancer Panel (Tier 2)

Intervention Type 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 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.

MACROGEN Pan Cancer Panel (Tier 2)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

MACROGEN

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jong-Seok Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SNUBH-17-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.