French National Observatory of the Patients With Non-small Cell Lung (NSCLC) and Molecular Testings
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Purpose
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.
| Condition |
|---|
|
Carcinoma, Non-Small-Cell Lung TPM4-ALK Fusion Protein Expression KRAS Gene Mutation BRAF Gene Mutation |
| Study Type: | Observational |
| 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
| Estimated Enrollment: | 17000 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Patients with advanced lung cancer |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with advanced non-small cell cancer
Inclusion Criteria:
- Advanced Non-small cell lung cancer (NSLC)
- Biomarkers analysis on hospital platforms
Exclusion Criteria:
-
Contacts and Locations| Contact: Pascale Missy | +33.1.56.81.10.45 | contact@ifct.fr |
Show 134 Study Locations| Principal Investigator: | Fabrice Barlesi, PhD, MD | IFCT, Aix Marseille Université / Assistance Publique Hôpitaux de Marseille |
More Information
Additional Information:
No publications provided
| Responsible Party: | Intergroupe Francophone de Cancerologie Thoracique |
| ClinicalTrials.gov Identifier: | NCT01700582 History of Changes |
| Other Study ID Numbers: | Biomarkers-France |
| Study First Received: | August 1, 2012 |
| Last Updated: | October 2, 2012 |
| Health Authority: | France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé |
Keywords provided by Intergroupe Francophone de Cancerologie Thoracique:
|
lung cancer biomarkers EGFR KRAS |
ALK HER2 PI3K BRAF |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms |
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013