Study on Fluids Associated to Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The diagnosis of lung cancer is the first cause of cancer deaths for man and woman. It requires invasive procedures (at least endoscopy, transthoracic puncture, or surgery). This study is about the set up of an innovative test for lung cancer prognosis, based on biopsies and surgical material : LungCancerTest, with the creation of a start-up in progress. The main goal of this study is to approve the diagnostic value of the molecular signature of the 26 genes (LungCancerTest) revealed in blood and respiratory fluids among patients with lung cancer.

Official Title
-----------------
Study on Fluids Associated to Lung Cancer, of the Ectopic Expression of Cancer Testis Gene and Mutation as Diagnostics and Prognosis Biomarkers

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

Intervention / Treatment
-----------------
* Biological: Blood and respiratory fluids sampling
* Procedure: Biopsy
* Procedure: Excised tissues


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criterias : Patients with lung cancer in stage 1-2, lung cancer of all histology kind eligible for surgery (Group 1). Patients with lung cancer in stage 3-4 (no adenocarcinoma or squamous) receiving classical or targeted chemotherapy on genetic anomalies (Group 2). Control patients : carriers of non-cancerous radiological anomalies : benign nodules, cicatricial lesions, infectious or inflammatory, paired with the two other groups by age, sex or tobacco (Group 3). Adults patients : over 18 years. Persons affiliated to national social security. Free signed consent. Exclusion Criterias : Persons referred to in articles L1121-5 to L1121-8 of CSP ( protected people) : pregnants, parturients or breastfeeding women, person deprived of liberty by judicial or administrative decision, person under legal protection.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1 lung cancer in stage 1-2<br>Group 1 : patient with lung cancer in stage 1-2, lung cancer of all histology kind eligible for surgery | Biological: Blood and respiratory fluids sampling<br>* In order to extract RNA (LungCancerTest) and DNA (mutation, reassortment).<br>Procedure: Excised tissues<br> <br> |
| Other: Group 2 lung cancer in stage 3-4<br>Group 2 : patient with lung cancer in stage 3-4 (no adenocarcinoma or squamous) receiving classical or targeted chemotherapy on genetic anomalies. | Biological: Blood and respiratory fluids sampling<br>* In order to extract RNA (LungCancerTest) and DNA (mutation, reassortment).<br>Procedure: Biopsy<br> <br> |
| Other: Group 3 : control patients<br>Group 3 control patients : carriers of non-cancerous radiological anomalies : benign nodules, cicatricial lesions, infectious or inflammatory, paired with the two other groups by age, sex or tobacco. | Biological: Blood and respiratory fluids sampling<br>* In order to extract RNA (LungCancerTest) and DNA (mutation, reassortment).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of : DNA | From plasma or respiratory fluids, with Qiagen QIAamp MinElute Virus Spin kit. Picogreen technique (fluorimétrie) with the device Qubit 2.0 Characterization of DNA by migration on revealed agarose gel in presence of ethidium bromide Study of DNA (mutation, reassortment) with New Generation Sequencing materiel. | Half a day | 
| Quantification of : RNA | From plasma or respiratory fluids, with Qiagen QIAamp MinElute Virus Spin kit. Picogreen technique (fluorimétrie) with the device Qubit 2.0 Characterization of RNA with an Agilent chip Study of RNA (LungCancerTest) with PCR-Array prototype to show the expression of the molecular signature (Cancer Testis genes). | Half a day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer lung, Fluids, LungCancerTest, radiological anomalies, non-cancerous, carriers, Patient reference