Feasibility of Bronchial Washing Fluid for Molecular Testing With Next Generation Sequencing in Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This is a single center, clinical trial evaluating the relevance of intratumoral washing for detection of generic alteration with Next Generation Sequencing.

Detailed Description
-----------------
This is a prospective, single-arm, open-label study to assess evaluate the relevance of intratumoral washing by ultrathin bronchoscopy (outer diameter; 3mm) for detection of genetic alterations using Next Generation Sequencing in patients with NSCLC.

Official Title
-----------------
Feasibility of Bronchial Washing Fluid for Molecular Testing With Next Generation Sequencing in Lung Cancer

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

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrathin bronchoscopy with intratumoral washing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 20 years Obtained written informed consent Subjects suspected with lung cancer on computed tomography or diagnosed with lung cancer by histology or cytology Subjects who plan to undergo tissue or liquid biopsy for genetic alteration with Next Generation Sequencing Exclusion Criteria: Patients who withdraw informed consent Patients who are unable to undergo liquid biopsy (plasma) and tissue biopsy for genetic alteration with Next Generation Sequencing based on the investigator's judgement

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrathin bronchoscopy with intratumoral washing<br>Each subject suspected or diagnosed of lung cancer will undergo bronchoscopic procedure for generic alteration with Next Generation Sequencing. | Diagnostic Test: Ultrathin bronchoscopy with intratumoral washing<br>* Each subject suspected or diagnosed of lung cancer will undergo bronchoscopic procedure. First, ultrathin bronchoscope is inserted and placed within tumor under radial EBUS, virtual bronchoscopic navigation, and fluoroscopy guidance. Then, intratumoral washing is performed. Subsequently, transbronchial lung biopsy is performed under radial EBUS, virtual bronchoscopic navigation, and fluoroscopy guidance.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic alteration with Next Generation Sequencing detection rate in intratumoral washing fluid | Detection rate is defined as the number of genetic alteration with Next Generation Sequencing detection divided by the total attempts of intratumoral washing by ultrathin bronchoscopy. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance rate of genetic alteration with Next Generation Sequencing detection rate among intratumoral washing fluid, plasma, and tissue | The concordance rate of genetic alteration with Next Generation Sequencing detection rate in intratumoral washing fluid, compared with plasma and tissue (gold standard). | through study completion, an average of 1 year | 
| Turn-around time | The duration between an order request and the task completion in in intratumoral washing fluid compared with plasma and tissue (gold standard). | through study completion, an average of 1 year | 
| Genetic alteration with Next Generation Sequencing sensitivity & specificity in intratumoral washing fluid | The sensitivity and specificity of genetic alteration with Next Generation Sequencing in intratumoral washing fluid compared with tissue (gold standard). | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchoscopy, Liquid biopsy, Lung Cancer, Next Generation Sequencing