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

Study Overview
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Brief Summary
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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
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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.

Official Title
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French National Observatory of the Patients With Non-small Cell Lung (NSCLC) Benefiting From a Molecular Test on the Hospital Platforms of Molecular Genetics.

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

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Advanced Non-small cell lung cancer (NSLC) Biomarkers analysis on hospital platforms Exclusion Criteria: - Histology other than NSLC

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with advanced lung cancer<br>Patients with advanced lung cancer | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EGF-R gene mutation in nationwide cohort | Number of patients with EGF-R gene mutation | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| K-RAS gene mutation in nationwide cohort | Number of patients with K-RAS gene mutation | 1 year | 
| EML4-ALK translocation in nationwide cohort | Number of patients with EML4-ALK translocation | 1 year | 
| BRAF gene mutation in nationwide cohort | Number of patients with BRAF gene mutation | 1 year | 
| HER2 gene mutation in nationwide cohort | Number of patients with HER2 gene mutation | 1 year | 
| PI3K gene mutation in nationwide cohort | Number of patients with PI3K gene mutation | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biomarkers, lung cancer, EGFR, KRAS, ALK, HER2, PI3K, BRAF, IFCT