Mutation Detection of EBUS-TBNA Specimens Using NGS

Study Overview
=================
Brief Summary
-----------------
The objective of the study was to compare the value of routine gene testing and next-generation sequencing (NGS) in detecting gene mutations of small specimens obtained by endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) and get the knowledge of how many EBUS-TBNA samples were adequate for NGS.

Detailed Description
-----------------
Some gene mutations can direct individualized treatment. The routine gene testing of EGFR, ROS1 and ALK is direct sequencing, Reverse transcription quantitative real-time polymerase chain reaction (RT-QPCR) and fluorescent in situ hybridization (FISH) or immunohistochemistry (IHC). Next-generation sequencing (NGS) is a new technique, which is more sensitive than routine techniques. So we decided to compare the value of gene testing between routine method and NGS in EBUS-TBNA specimens and get the knowledge of how many EBUS-TBNA samples were adequate for NGS. The study was designed as a prospective and single center study. Seventy patients will be enrolled into the study and the clinical data of the patients, including his smoke history, cancer history, occupation exposure and so on, will be collected and recorded in a case report form. For the patients recruited in the study, the lymph nodes suspected to be malignant will be obtained by EBUS-TBNA. Samples will be sent to Pathology Department of Shanghai Chest Hospital and will be processed with paraffin-embedded, and for those diagnosed with nonsquamous NSCLC, routine gene testing of EGFR, ROS1 and ALK will be performed. And the rest tissues will be extracted with DNA and performed gene mutations using NGS for these qualified DNA samples.

Official Title
-----------------
Mutation Detection of Small Specimens Obtained by Endobronchial Ultrasound Transbronchial Needle Aspiration in Advanced Nonsquamous Non-small Cell Lung Cancer Using Next-generation Sequencing

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Procedure: Routine gene testing
* Procedure: Next-generation sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are suspected with nonsquamous non-small cell lung cancer according to the clinical, lab examination and imaging data and had never been diagnosed as primary lung cancer before will be enrolled into the study. The clinical stage of the patients should be in stage IIIA-IV judged by the imaging data and can't receive surgery initially. 4. There exist at least one lesions that can be obtained by EBUS-TBNA. Exclusion Criteria: The patient is highly suspected to benign lesion, small cell lung cancer and squamous cell carcinoma according to the clinical data. Surgery was considered to be the primary treatment. Patients who are diagnosed with lung cancer and received treatment with drugs or recurrent with lung cancer will be excluded. Severe cardiopulmonary dysfunction and other indications that can't tolerate bronchoscopy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Routine gene testing<br>Routine gene testing of EGFR, ROS1 and ALK will be performed on those diagnosed with nonsquamous NSCLC. | Procedure: Routine gene testing<br>* For those diagnosed with nonsquamous NSCLC, routine gene testing including EGFR, ROS1 and ALK will be performed.<br>|
| Experimental: Next-generation sequencing<br>Routine gene testing was performed in those diagnosed with nonsquamous NSCLC. NGS will be performed on these that have adequate rest tissues. | Procedure: Next-generation sequencing<br>* For those diagnosed with nonsquamous NSCLC and have done routine gene testing, NGS will be perform on those that have adequate rest tissues.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Values of gene testing between routine method and NGS in EBUS-TBNA specimens |  | Up to one and a half years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The quantity of EBUS-TBNA samples adequate for NGS. |  | Up to one and a half years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gene testing, Endobronchial ultrasound (EBUS), Next-generation sequencing (NGS), Small biopsies