French National Observatory of the Patients With Non-small Cell Lung (NSCLC) and Molecular Testings
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.
Carcinoma, Non-Small-Cell Lung
TPM4-ALK Fusion Protein Expression
KRAS Gene Mutation
BRAF Gene Mutation
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||French National Observatory of the Patients With Non-small Cell Lung (NSCLC) Benefiting From a Molecular Test on the Hospital Platforms of Molecular Genetics.|
- EGF-R gene mutation in nationwide cohort [ Time Frame: 1 Year ] [ Designated as safety issue: No ]Number of patients with EGF-R gene mutation
- K-RAS gene mutation in nationwide cohort [ Time Frame: 1 year ] [ Designated as safety issue: No ]Number of patients with K-RAS gene mutation
- EML4-ALK translocation in nationwide cohort [ Time Frame: 1 year ] [ Designated as safety issue: No ]Number of patients with EML4-ALK translocation
|Study Start Date:||April 2012|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
|Patients with advanced lung cancer|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700582
Show 133 Study Locations
|Principal Investigator:||Fabrice Barlesi, PhD, MD||IFCT, Aix Marseille Université / Assistance Publique Hôpitaux de Marseille|