Study on Fluids Associated to Lung Cancer

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Biological: Blood and respiratory fluids sampling; Procedure: Excised tissues; Procedure: Biopsy

• Registration Number: NCT02853006
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-08-02
• Primary Completion: 2019-09
• Study Completion: 2020-02
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 lung cancer in stage 1-2	Excised tissues	Group 1 : patient with lung cancer in stage 1-2, lung cancer of all histology kind eligible for surgery
Group 2 lung cancer in stage 3-4	Biopsy	Group 2 : patient with lung cancer in stage 3-4 (no adenocarcinoma or squamous) receiving classical or targeted chemotherapy on genetic anomalies.
Group 1 lung cancer in stage 1-2	Blood and respiratory fluids sampling	Group 1 : patient with lung cancer in stage 1-2, lung cancer of all histology kind eligible for surgery
Group 3 : control patients	Blood and respiratory fluids sampling	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.
Group 2 lung cancer in stage 3-4	Blood and respiratory fluids sampling	Group 2 : patient with lung cancer in stage 3-4 (no adenocarcinoma or squamous) receiving classical or targeted chemotherapy on genetic anomalies.

Primary Outcome Measures

Name	Time	Method
Quantification of : DNA	Half a day	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.
Quantification of : RNA	Half a day	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).

Trial Locations

Locations (1)

UniversityHospitalGrenoble; 🇫🇷 La Tronche, France