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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:
NCT01700582
First received: August 1, 2012
Last updated: April 13, 2016
Last verified: April 2016
  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.

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    Number of patients with EGF-R gene mutation


Secondary Outcome Measures:
  • 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

  • BRAF gene mutation in nationwide cohort [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of patients with BRAF gene mutation

  • HER2 gene mutation in nationwide cohort [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of patients with HER2 gene mutation

  • PI3K gene mutation in nationwide cohort [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: August 1, 2012
Last Updated: April 13, 2016
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: French Data Protection Authority
Individual Participant Data  
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

ClinicalTrials.gov processed this record on August 22, 2016