ALK Gene Mutation, BRAF Gene Mutation, Carcinoma, Non-Small-Cell Lung, KRAS Gene Mutation
Conditions
Keywords
lung cancer, biomarkers, EGFR, KRAS, ALK, HER2, PI3K, BRAF, IFCT
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.
Interventions
None listed
Sponsors
Intergroupe Francophone de Cancerologie Thoracique
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Advanced Non-small cell lung cancer (NSLC) * Biomarkers analysis on hospital platforms
Exclusion criteria
\- Histology other than NSLC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EGF-R gene mutation in nationwide cohort | 1 Year | Number of patients with EGF-R gene mutation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| K-RAS gene mutation in nationwide cohort | 1 year | Number of patients with K-RAS gene mutation |
| EML4-ALK translocation in nationwide cohort | 1 year | Number of patients with EML4-ALK translocation |
| BRAF gene mutation in nationwide cohort | 1 year | Number of patients with BRAF gene mutation |
| HER2 gene mutation in nationwide cohort | 1 year | Number of patients with HER2 gene mutation |
| PI3K gene mutation in nationwide cohort | 1 year | Number of patients with PI3K gene mutation |
Countries
France
Outcome results
None listed