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NCT Number: NCT01700582

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

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).

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung ALK Gene Mutation BRAF Gene Mutation Bronchial Neoplasms Carcinoma, Bronchogenic KRAS Gene Mutation Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Calabet - Centre de Radiothérapie et d'Oncologie, Agen, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Histology other than NSLC

Treatment and study plan

Primary outcomes

  1. EGF-R gene mutation in nationwide cohort

    Time frame: 1 Year

    Number of patients with EGF-R gene mutation

Secondary outcomes

  1. K-RAS gene mutation in nationwide cohort

    Time frame: 1 year

    Number of patients with K-RAS gene mutation

  2. EML4-ALK translocation in nationwide cohort

    Time frame: 1 year

    Number of patients with EML4-ALK translocation

  3. BRAF gene mutation in nationwide cohort

    Time frame: 1 year

    Number of patients with BRAF gene mutation

  4. HER2 gene mutation in nationwide cohort

    Time frame: 1 year

    Number of patients with HER2 gene mutation

  5. PI3K gene mutation in nationwide cohort

    Time frame: 1 year

    Number of patients with PI3K gene mutation

Sponsors and collaborators

Lead sponsor

Intergroupe Francophone de Cancerologie Thoracique

Other

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 4, 2012
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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