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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01700582
First Posted: October 4, 2012
Last Update Posted: April 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique
  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).

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).


Condition
Carcinoma, Non-Small-Cell Lung ALK Gene Mutation 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.

Further study details as provided by Intergroupe Francophone de Cancerologie Thoracique:

Primary Outcome Measures:
  • EGF-R gene mutation in nationwide cohort [ Time Frame: 1 Year ]
    Number of patients with EGF-R gene mutation


Secondary Outcome Measures:
  • K-RAS gene mutation in nationwide cohort [ Time Frame: 1 year ]
    Number of patients with K-RAS gene mutation

  • EML4-ALK translocation in nationwide cohort [ Time Frame: 1 year ]
    Number of patients with EML4-ALK translocation

  • BRAF gene mutation in nationwide cohort [ Time Frame: 1 year ]
    Number of patients with BRAF gene mutation

  • HER2 gene mutation in nationwide cohort [ Time Frame: 1 year ]
    Number of patients with HER2 gene mutation

  • PI3K gene mutation in nationwide cohort [ Time Frame: 1 year ]
    Number of patients with PI3K gene mutation


Enrollment: 18858
Study Start Date: April 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with advanced lung cancer
Patients with advanced lung cancer

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with advanced non-small cell cancer
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Histology other than NSLC

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700582


  Show 133 Study Locations
Sponsors and Collaborators
Intergroupe Francophone de Cancerologie Thoracique
Investigators
Principal Investigator: Fabrice Barlesi, PhD, MD IFCT, Aix Marseille Université / Assistance Publique Hôpitaux de Marseille
  More Information

Additional Information:
Publications:
Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier: NCT01700582     History of Changes
Other Study ID Numbers: Biomarkers-France
First Submitted: August 1, 2012
First Posted: October 4, 2012
Last Update Posted: April 14, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Intergroupe Francophone de Cancerologie Thoracique:
lung cancer
biomarkers
EGFR
KRAS
ALK
HER2
PI3K
BRAF

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases