French National Observatory of the Patients With Non-small Cell Lung (NSCLC) and Molecular Testings

Intergroupe Francophone de Cancerologie Thoracique

Status: Completed

Conditions: KRAS Gene Mutation; Carcinoma, Non-Small-Cell Lung; ALK Gene Mutation; BRAF Gene Mutation

Study type: Observational

Funder types: Other

Identifiers

NCT01700582

Biomarkers-France

Details and patient eligibility

About

The French National Cancer Institute (INCa) support a 28 hospital platforms network for molecular testing of cancer patients. These platforms routinely assess a panel of biomarkers in order to speed up access of French cancer patients to targeted therapies (commercially available or through clinical trials).

The objective of the BIOMARKERS-France study is to describe the epidemiological, clinical and molecular characteristics of these patients and their tumors and to assess the impact of these analyzes on their treatment (ie bio-guided therapy) as well as outcomes (response rate, progression free and overall survival).

Full description

The French National Cancer Institute (INCa) support a 28 hospital platforms network for molecular testing of cancer patients. These platforms routinely assess a panel of biomarkers in order to speed up access of French cancer patients to targeted therapies (commercially available or through clinical trials).

Regarding stage IV non-squamous NSCLC patients, 7 biomarkers are assessed including activating EGFR mutations, EML4-ALK translocation and EGFR T790M, KRAS, BRAF, HER2 and PI3KCA mutations. In 2012, up to 17 to 20,000 patients will be tested on this platform network.

The objective of the BIOMARKERS-France study is to describe the epidemiological, clinical and molecular characteristics of these patients and their tumors and to assess the impact of these analyzes on their treatment (ie bio-guided therapy) as well as outcomes (response rate, progression free and overall survival).

This study will collect, in a prospective way, data from a unique national cohort in order to guide future decisions regarding biomarker assessments (type? Number? Methods? Etc) in connexion with all the other research works currently ongoing in France.

Enrollment: 17,664 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced Non-small cell lung cancer (NSLC)
• Biomarkers analysis on hospital platforms

Exclusion criteria

• Histology other than NSLC

Trial design

17,664 participants in 1 patient group

Patients with advanced lung cancer

Description:

Patients with advanced lung cancer