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

Completed

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

• Registration Number: NCT01700582
• Lead Sponsor: Intergroupe Francophone de Cancerologie Thoracique

Brief Summary

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).

Detailed 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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-08-01
• Study First Submitted QC: 2012-10-02
• Study First Posted: 2012-10-04
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17664

Inclusion Criteria

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

Exclusion Criteria

• Histology other than NSLC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EGF-R gene mutation in nationwide cohort	1 Year	Number of patients with EGF-R gene mutation

Secondary Outcome Measures

Name	Time	Method
BRAF gene mutation in nationwide cohort	1 year	Number of patients with BRAF gene mutation
EML4-ALK translocation in nationwide cohort	1 year	Number of patients with EML4-ALK translocation
PI3K gene mutation in nationwide cohort	1 year	Number of patients with PI3K gene mutation
K-RAS gene mutation in nationwide cohort	1 year	Number of patients with K-RAS gene mutation
HER2 gene mutation in nationwide cohort	1 year	Number of patients with HER2 gene mutation

Trial Locations

Locations (132)

Clinique Calabet - Centre de Radiothérapie et d'Oncologie; 🇫🇷 Agen, France

Clinique Claude Bernard; 🇫🇷 Albi, France

Clinique de l'Europe; 🇫🇷 Amiens, France

CHU d'Angers; 🇫🇷 Angers, France

Hôpital Privé d'Antony; 🇫🇷 Antony, France

CHIC; 🇫🇷 Aulnay-Sous-Bois, France

Auxerre - CH; 🇫🇷 Auxerre, France

CH d'Avignon; 🇫🇷 Avignon, France

CH de la Côte Basque; 🇫🇷 Bayonne, France

CHU Besancon - Pneumologie; 🇫🇷 Besancon, France

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