Clinical trial NCT01700582: French National Observatory of the Patients With Non-small Cell Lung (NSCLC) and Molecular Testings
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
ALK Gene Mutation
KRAS Gene Mutation
BRAF Gene Mutation
Keywords: lung cancer
biomarkers
EGFR
KRAS
ALK
HER2
PI3K
BRAF
IFCT
Lead sponsor: Intergroupe Francophone de Cancerologie Thoracique
Sponsor class: OTHER
First posted: 2012-10-04
Enrollment: 17664
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced non-small cell cancer

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- Histology other than NSLC

Primary outcomes:
measure: EGF-R gene mutation in nationwide cohort
timeFrame: 1 Year
Secondary outcomes:
measure: K-RAS gene mutation in nationwide cohort
timeFrame: 1 year
measure: EML4-ALK translocation in nationwide cohort
timeFrame: 1 year
measure: BRAF gene mutation in nationwide cohort
timeFrame: 1 year
measure: HER2 gene mutation in nationwide cohort
timeFrame: 1 year
measure: PI3K gene mutation in nationwide cohort
timeFrame: 1 year
Other outcomes:
Locations:
city: Agen
country: France
facility: Clinique Calabet - Centre de Radiothérapie et d'Oncologie
city: Albi
country: France
facility: Clinique Claude Bernard
city: Amiens
country: France
facility: Clinique de l'Europe
city: Angers
country: France
facility: CHU d'Angers
city: Antony
country: France
facility: Hôpital Privé d'Antony
city: Aulnay-Sous-Bois
country: France
facility: CHIC
city: Auxerre
country: France
facility: Auxerre - CH
city: Avignon
country: France
facility: CH d'Avignon
city: Bayonne
country: France
facility: CH de la Côte Basque
city: Besancon
country: France
facility: CHU Besancon - Pneumologie
city: Blois
country: France
facility: Blois - CH
city: Bobigny
country: France
facility: CHU Avicenne
city: Boulogne
country: France
facility: Hôpital Ambroise Paré - Pneumologie
city: Bourg en Bresse
country: France
facility: Hôpital Fleyriat
city: Briançon
country: France
facility: Hôpital de Briançon
city: Béziers
country: France
facility: CH de Béziers
city: Caen
country: France
facility: CHU Côte de Nâcre
city: Cahors
country: France
facility: Cahors - CH
city: Cannes
country: France
facility: CH de Cannes
city: Chambray Les Tours
country: France
facility: Chambray Les Tours - Clinique Léonard de Vinci
city: Chartres
country: France
facility: CH de Chartres Hôpital Louis Pasteur
city: Chevilly-Larue
country: France
facility: Chevilly-Larue - CH
city: Cholet
country: France
facility: Hôpital de Cholet - Pneumologie
city: Clamart
country: France
facility: Hôpital Percy-Armées - Pneumologie
city: Colmar
country: France
facility: Hôpital Pasteur
city: Cornebarrieu
country: France
facility: Clinique des Cèdres
city: Créteil
country: France
facility: Créteil - CHI
city: Dax
country: France
facility: Dax - CH
city: Denain
country: France
facility: Denain - CH
city: Dijon
country: France
facility: Dijon - CAC
city: Dijon
country: France
facility: Dijon - CHU
city: Draguignan
country: France
facility: Draguignan - CH
city: Dreux
country: France
facility: CH de Dreux
city: Elbeuf
country: France
facility: Elbeuf - CH
city: Epinal
country: France
facility: Epinal - CH
city: Ermont
country: France
facility: Ermont - Clinique Claude Bernard
city: Evreux
country: France
facility: Evreux - CH
city: Flers
country: France
facility: Flers - CH
city: Gap
country: France
facility: CHICAS Site de Gap
city: Grenoble
country: France
facility: CHRU Grenoble
city: Helfaut
country: France
facility: Saint Omer - CHI
city: Jonzac
country: France
facility: Jonzac - CH
city: La Roche Sur Yon
country: France
facility: La Roche Sur Yon - CH
city: Le Havre
country: France
facility: Le Havre - HPE
city: Le Mans
country: France
facility: Le Mans - Centre Hospitalier
city: Le Mans
country: France
facility: Le Mans - Clinique Victor Hugo
city: Lens
country: France
facility: CH Dr Schaffner de Lens
city: Lille
country: France
facility: CHU (Hôpital Calmette) - Pneumologie
city: Lille
country: France
facility: Lille - Hôpital Calmette
city: Limoges
country: France
facility: Limoges - Hôpital du Cluzeau
city: Liévin
country: France
facility: Liévin - polyclinique de Riaumont
city: Longjumeau
country: France
facility: CH de Longjumeau
city: Lorient
country: France
facility: Lorient - CHBS
city: Lormont
country: France
facility: Clinique des 4 Pavillons
city: Lyon
country: France
facility: Lyon - Clinique Mutualiste
city: Lyon
country: France
facility: Clinique Mutualiste Eugène André
city: Lyon
country: France
facility: HIA Desgenettes
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Lyon
country: France
facility: Lyon - Hôpital Louis Pradel (Pneumologie)
city: Mantes La Jolie
country: France
facility: Mantes La Jolie - CH
city: Marseille
country: France
facility: Marseille - Hôpital Sainte Marguerite
city: Marseille
country: France
facility: Marseille - CRLCC
city: Maubeuge
country: France
facility: Polyclinique du Parc
city: Meaux
country: France
facility: Meaux - CH
city: Metz
country: France
facility: Metz - CHR
city: Metz
country: France
facility: Metz - Clinique Claude Bernard
city: Metz
country: France
facility: Metz - Belle Isle
city: Mont de Marsan
country: France
facility: Mont de Marsan - CH
city: Montpellier
country: France
facility: Montpellier - Clinique Clémentville
city: Montpellier
country: France
facility: Montpellier - CHRU
city: Moulins
country: France
facility: Moulins - CH
city: Mulhouse
country: France
facility: Mulhouse - CH
city: Nancy
country: France
facility: CHU Nancy
city: Nancy
country: France
facility: Nancy - Polyclinique Gentilly
city: Nanterre
country: France
facility: Nanterre - CH
city: Nantes
country: France
facility: Nantes - Centre René Gauducheau
city: Nantes
country: France
facility: Hôpital Laënnec - CHU de Nantes
city: Narbonne
country: France
facility: Narbonne - Polyclinique Le Languedoc
city: Neuilly
country: France
facility: Neuilly - Hôpital Américain de Paris
city: Nevers
country: France
facility: Nevers - CH
city: Nice
country: France
facility: Nice - CAC
city: Nîmes
country: France
facility: Nîmes - Clinique Valdegour
city: Nîmes
country: France
facility: CHU
city: Orléans
country: France
facility: Orléans - CH
city: Paris
country: France
facility: Paris - Saint Louis
city: Paris
country: France
facility: Paris - hôpital Saint-Antoine
city: Paris
country: France
facility: GH Paris Saint-Joseph
city: Paris
country: France
facility: Hôpital Bichat - Claude - Bernard
city: Paris
country: France
facility: Hôpital du Val de Grâce
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Hôpital Tenon
city: Paris
country: France
facility: Paris - Curie
city: Pau
country: France
facility: Pau - CH
city: Perpignan
country: France
facility: Perpignan - Centre Catalan d'Oncologie
city: Perpignan
country: France
facility: Perpignan - Ch
city: Pierre Bénite
country: France
facility: Lyon Sud
city: Poitiers
country: France
facility: CHU
city: Pontoise
country: France
facility: Pontoise - CH
city: Périgueux
country: France
facility: CH de Périgueux
city: Reims
country: France
facility: Reims - CHU
city: Reims
country: France
facility: Reims - CRLCC
city: Rennes
country: France
facility: Rennes - CHU
city: Roanne
country: France
facility: CHG de Roanne
city: Rodez
country: France
facility: Rodez - CH
city: Roncq
country: France
facility: Roncq - Clinique Saint-Roch
city: Roubaix
country: France
facility: Roubaix - CH
city: Rouen
country: France
facility: Rouen - CHU
city: Rouen
country: France
facility: Centre Frederic Joliot
city: Saint Brieuc
country: France
facility: Saint Brieuc - CHG
city: Saint Nazaire
country: France
facility: Saint Nazaire - Centre Etienne Dolet
city: Saint Priest en Jarez
country: France
facility: Saint Priest en Jarez - ICL
city: Saint Quentin
country: France
facility: Saint Quentin - CH
city: Saint-Malo
country: France
facility: Saint-Malo - CH
city: Saint-Nazaire
country: France
facility: Saint-Nazaire - CH
city: Saverne
country: France
facility: Saverne - CH
city: Senlis
country: France
facility: Senlis - CH
city: Strasbourg
country: France
facility: Strasbourg - NHC
city: Suresnes
country: France
facility: Suresnes - Hopital Foch
city: Thonon les bains
country: France
facility: Thonon les bains
city: Toulon
country: France
facility: Toulon - CHI
city: Toulon
country: France
facility: Toulon - HIA
city: Toulouse
country: France
facility: Clinique Saint Jean du Languedoc
city: Toulouse
country: France
facility: Toulouse - CHU Larrey
city: Toulouse
country: France
facility: Toulouse - Clinique Pasteur
city: Tours
country: France
facility: Tours - CHU
city: Troyes
country: France
facility: Troyes - CH
city: Valenciennes
country: France
facility: Valenciennes - Clinique
city: Verdun
country: France
facility: Verdun - CHG
city: Vesoul
country: France
facility: Vesoul - CHI
city: Vesoul
country: France
facility: CHI de la Haute-Saône - Pneumologie
city: Vienne
country: France
facility: Vienne - CH
city: Villejuif
country: France
facility: Villejuif - Institut Gustave Roussy
city: Vénissieux
country: France
facility: Clinique Mutualiste Les Portes du Sud
Study officials:
affiliation: IFCT, Aix Marseille Université / Assistance Publique Hôpitaux de Marseille
name: Fabrice Barlesi, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
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