Liquid Biopsy for Detection of Driver Mutation in NSCLC

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the diagnostic and prognostic efficacy of liquid biopsy in different specimens and in different methods compared with tissue detection .

Detailed Description
-----------------
Collect plasma and other specimens from patients who are newly diagnosed with NSCLC or with drug-resistant and plan to receive gene detection to complete the diagnostic test for liquid biopsy .Participants who come from diagnostic test and plan to receive tyrosine kinase inhibitors (TKI) therapy will be collected plasma and other specimens every month during the regiments and monitor the changes of driver motion to predict the prognosis of targeted therapy.

Official Title
-----------------
Liquid Biopsy for Detection of Driver Mutation in Diagnostic and Prognostic of NSCLC

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Genetic: detection of driver mutation


Participation Criteria
=================
Eligibility Criteria
-----------------
cohort 1 Inclusion Criteria: patients newly diagnosed with NSCLC confirmed by tissue biopsy and going to receive the detection of gene mutation or patients have obtained drug-resistance after receiving molecular target therapy and plan to re-biopsy. Age ≥ 18 years newly diagnosed patients have not received TKI and chemotherapy patients who are drug-resistant have not received next-generation TKI Exclusion Criteria: patients who have more than one type of carcinoma patients who reject to sign the informed consent from cohort 2 Inclusion Criteria: patients from cohort1 with sensitive driver mutation and plan to receive TKI therapy patients will have regular follow-up in Chinese people liberation army general hospital every month. Exclusion Criteria: patients who are refused to provide the informed consent from

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cohort 1<br>Participants are recruited for diagnostic test | Genetic: detection of driver mutation<br>* participants are received gene detection via the liquid biopsy<br>|
| cohort 2<br>participants are recruited for follow-up | Genetic: detection of driver mutation<br>* participants are received gene detection via the liquid biopsy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concordance between tissue and plasma using detection method such as droplet digital PCR(ddPCR) or next generation sequencing(NGS) to detect the driver mutation in NSCLC |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concordance between tissue and other specimens using detection method such as droplet digital PCR(ddPCR) or next generation sequencing(NGS) to detect the driver mutation in NSCLC |  | 6 months | 
| changes of driver mutation in quality and quantity in the process of targeted treatment to predict the prognosis |  | 5 years | 
| Progress-free survival(PFS) in patients who have had driver mutation and received the molecular target therapy | compare the PFS between each participants via the change of driver mutation | 3 years | 
| Overall survival(OS) in patients who had driver mutation and received the molecular target therapy | compare the OS between each participants via the change of driver mutation | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSCLC, liquid biopsy, driver mutation