MedPath

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

Completed
Conditions
Carcinoma, Non-Small-Cell Lung
KRAS Gene Mutation
ALK Gene Mutation
BRAF Gene Mutation
Registration Number
NCT01700582
Lead Sponsor
Intergroupe Francophone de Cancerologie Thoracique
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
17664
Inclusion Criteria
  • Advanced Non-small cell lung cancer (NSLC)
  • Biomarkers analysis on hospital platforms
Exclusion Criteria
  • Histology other than NSLC

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
EGF-R gene mutation in nationwide cohort1 Year

Number of patients with EGF-R gene mutation

Secondary Outcome Measures
NameTimeMethod
BRAF gene mutation in nationwide cohort1 year

Number of patients with BRAF gene mutation

EML4-ALK translocation in nationwide cohort1 year

Number of patients with EML4-ALK translocation

PI3K gene mutation in nationwide cohort1 year

Number of patients with PI3K gene mutation

K-RAS gene mutation in nationwide cohort1 year

Number of patients with K-RAS gene mutation

HER2 gene mutation in nationwide cohort1 year

Number of patients with HER2 gene mutation

Trial Locations

Locations (132)

Meaux - CH

🇫🇷

Meaux, France

Orléans - CH

🇫🇷

Orléans, France

Paris - Saint Louis

🇫🇷

Paris, France

CH de la Côte Basque

🇫🇷

Bayonne, France

Dax - CH

🇫🇷

Dax, France

CHU d'Angers

🇫🇷

Angers, France

Clinique Calabet - Centre de Radiothérapie et d'Oncologie

🇫🇷

Agen, France

Clinique de l'Europe

🇫🇷

Amiens, France

Auxerre - CH

🇫🇷

Auxerre, France

CH d'Avignon

🇫🇷

Avignon, France

Montpellier - CHRU

🇫🇷

Montpellier, France

Nancy - Polyclinique Gentilly

🇫🇷

Nancy, France

CHICAS Site de Gap

🇫🇷

Gap, France

Jonzac - CH

🇫🇷

Jonzac, France

La Roche Sur Yon - CH

🇫🇷

La Roche Sur Yon, France

Lille - Hôpital Calmette

🇫🇷

Lille, France

Mulhouse - CH

🇫🇷

Mulhouse, France

Hôpital Laënnec - CHU de Nantes

🇫🇷

Nantes, France

CH de Périgueux

🇫🇷

Périgueux, France

Paris - hôpital Saint-Antoine

🇫🇷

Paris, France

Hôpital du Val de Grâce

🇫🇷

Paris, France

Nanterre - CH

🇫🇷

Nanterre, France

Nevers - CH

🇫🇷

Nevers, France

Nice - CAC

🇫🇷

Nice, France

Hôpital Européen Georges Pompidou

🇫🇷

Paris, France

Reims - CHU

🇫🇷

Reims, France

Nantes - Centre René Gauducheau

🇫🇷

Nantes, France

GH Paris Saint-Joseph

🇫🇷

Paris, France

CHU

🇫🇷

Poitiers, France

Hôpital Bichat - Claude - Bernard

🇫🇷

Paris, France

Hôpital Tenon

🇫🇷

Paris, France

Clinique Claude Bernard

🇫🇷

Albi, France

CHU Côte de Nâcre

🇫🇷

Caen, France

HIA Desgenettes

🇫🇷

Lyon, France

Lyon - Hôpital Louis Pradel (Pneumologie)

🇫🇷

Lyon, France

Pau - CH

🇫🇷

Pau, France

Perpignan - Centre Catalan d'Oncologie

🇫🇷

Perpignan, France

Perpignan - Ch

🇫🇷

Perpignan, France

Saint-Nazaire - CH

🇫🇷

Saint-Nazaire, France

Valenciennes - Clinique

🇫🇷

Valenciennes, France

Suresnes - Hopital Foch

🇫🇷

Suresnes, France

Hôpital Privé d'Antony

🇫🇷

Antony, France

CHU Avicenne

🇫🇷

Bobigny, France

CHIC

🇫🇷

Aulnay-Sous-Bois, France

CHU Besancon - Pneumologie

🇫🇷

Besancon, France

Blois - CH

🇫🇷

Blois, France

Hôpital Ambroise Paré - Pneumologie

🇫🇷

Boulogne, France

Hôpital Fleyriat

🇫🇷

Bourg en Bresse, France

Hôpital de Briançon

🇫🇷

Briançon, France

CH de Béziers

🇫🇷

Béziers, France

Cahors - CH

🇫🇷

Cahors, France

CH de Cannes

🇫🇷

Cannes, France

Chambray Les Tours - Clinique Léonard de Vinci

🇫🇷

Chambray Les Tours, France

CH de Chartres Hôpital Louis Pasteur

🇫🇷

Chartres, France

Chevilly-Larue - CH

🇫🇷

Chevilly-Larue, France

Hôpital de Cholet - Pneumologie

🇫🇷

Cholet, France

Hôpital Percy-Armées - Pneumologie

🇫🇷

Clamart, France

Hôpital Pasteur

🇫🇷

Colmar, France

Clinique des Cèdres

🇫🇷

Cornebarrieu, France

Créteil - CHI

🇫🇷

Créteil, France

Denain - CH

🇫🇷

Denain, France

Dijon - CAC

🇫🇷

Dijon, France

Dijon - CHU

🇫🇷

Dijon, France

Draguignan - CH

🇫🇷

Draguignan, France

CH de Dreux

🇫🇷

Dreux, France

Elbeuf - CH

🇫🇷

Elbeuf, France

Epinal - CH

🇫🇷

Epinal, France

Ermont - Clinique Claude Bernard

🇫🇷

Ermont, France

Evreux - CH

🇫🇷

Evreux, France

Flers - CH

🇫🇷

Flers, France

CHRU Grenoble

🇫🇷

Grenoble, France

Saint Omer - CHI

🇫🇷

Helfaut, France

Le Havre - HPE

🇫🇷

Le Havre, France

Le Mans - Centre Hospitalier

🇫🇷

Le Mans, France

Le Mans - Clinique Victor Hugo

🇫🇷

Le Mans, France

CH Dr Schaffner de Lens

🇫🇷

Lens, France

CHU (Hôpital Calmette) - Pneumologie

🇫🇷

Lille, France

Limoges - Hôpital du Cluzeau

🇫🇷

Limoges, France

Liévin - polyclinique de Riaumont

🇫🇷

Liévin, France

CH de Longjumeau

🇫🇷

Longjumeau, France

Lorient - CHBS

🇫🇷

Lorient, France

Clinique des 4 Pavillons

🇫🇷

Lormont, France

Lyon - Clinique Mutualiste

🇫🇷

Lyon, France

Clinique Mutualiste Eugène André

🇫🇷

Lyon, France

Hôpital de la Croix Rousse

🇫🇷

Lyon, France

Mantes La Jolie - CH

🇫🇷

Mantes La Jolie, France

Marseille - Hôpital Sainte Marguerite

🇫🇷

Marseille, France

Marseille - CRLCC

🇫🇷

Marseille, France

Polyclinique du Parc

🇫🇷

Maubeuge, France

Metz - CHR

🇫🇷

Metz, France

Metz - Clinique Claude Bernard

🇫🇷

Metz, France

Metz - Belle Isle

🇫🇷

Metz, France

Mont de Marsan - CH

🇫🇷

Mont de Marsan, France

Montpellier - Clinique Clémentville

🇫🇷

Montpellier, France

Moulins - CH

🇫🇷

Moulins, France

CHU Nancy

🇫🇷

Nancy, France

Narbonne - Polyclinique Le Languedoc

🇫🇷

Narbonne, France

Neuilly - Hôpital Américain de Paris

🇫🇷

Neuilly, France

Nîmes - Clinique Valdegour

🇫🇷

Nîmes, France

Lyon Sud

🇫🇷

Pierre Bénite, France

Clinique Saint Jean du Languedoc

🇫🇷

Toulouse, France

Pontoise - CH

🇫🇷

Pontoise, France

Senlis - CH

🇫🇷

Senlis, France

Reims - CRLCC

🇫🇷

Reims, France

Rennes - CHU

🇫🇷

Rennes, France

CHG de Roanne

🇫🇷

Roanne, France

Rodez - CH

🇫🇷

Rodez, France

Roncq - Clinique Saint-Roch

🇫🇷

Roncq, France

Roubaix - CH

🇫🇷

Roubaix, France

Rouen - CHU

🇫🇷

Rouen, France

Saint Brieuc - CHG

🇫🇷

Saint Brieuc, France

Saint-Malo - CH

🇫🇷

Saint-Malo, France

Centre Frederic Joliot

🇫🇷

Rouen, France

Saint Nazaire - Centre Etienne Dolet

🇫🇷

Saint Nazaire, France

Saint Priest en Jarez - ICL

🇫🇷

Saint Priest en Jarez, France

Saint Quentin - CH

🇫🇷

Saint Quentin, France

Saverne - CH

🇫🇷

Saverne, France

Toulon - CHI

🇫🇷

Toulon, France

Toulon - HIA

🇫🇷

Toulon, France

Verdun - CHG

🇫🇷

Verdun, France

Strasbourg - NHC

🇫🇷

Strasbourg, France

Thonon les bains

🇫🇷

Thonon les bains, France

Tours - CHU

🇫🇷

Tours, France

Troyes - CH

🇫🇷

Troyes, France

Toulouse - CHU Larrey

🇫🇷

Toulouse, France

Vesoul - CHI

🇫🇷

Vesoul, France

CHI de la Haute-Saône - Pneumologie

🇫🇷

Vesoul, France

Vienne - CH

🇫🇷

Vienne, France

Villejuif - Institut Gustave Roussy

🇫🇷

Villejuif, France

Clinique Mutualiste Les Portes du Sud

🇫🇷

Vénissieux, France

Toulouse - Clinique Pasteur

🇫🇷

Toulouse, France

Paris - Curie

🇫🇷

Paris, France

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