Study on Fluids Associated to Lung Cancer (ECTOPIC/MUTAS)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Lung Cancer

Treatments: Procedure: Excised tissues; Procedure: Biopsy; Biological: Blood and respiratory fluids sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT02853006

38RC15.099

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 3 patient groups

Group 1 lung cancer in stage 1-2

Other group

Description:

Group 1 : patient with lung cancer in stage 1-2, lung cancer of all histology kind eligible for surgery

Treatment:

Biological: Blood and respiratory fluids sampling

Procedure: Excised tissues

Group 2 lung cancer in stage 3-4

Other group

Description:

Group 2 : patient with lung cancer in stage 3-4 (no adenocarcinoma or squamous) receiving classical or targeted chemotherapy on genetic anomalies.

Treatment:

Biological: Blood and respiratory fluids sampling

Procedure: Biopsy

Group 3 : control patients

Other group

Description:

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.

Treatment:

Biological: Blood and respiratory fluids sampling