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

French National Observatory of the Patients With Non-small Cell Lung (NSCLC) Benefiting From a Molecular Test on the Hospital Platforms of Molecular Genetics.

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).

Study Overview

• Status: Completed
• Conditions: Carcinoma, Non-Small-Cell Lung; KRAS Gene Mutation; ALK Gene Mutation; BRAF Gene Mutation

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.

• Study Type: Observational
• Enrollment (Actual): 17664

Contacts and Locations

Study Locations

• France
  • Agen, France
    • Clinique Calabet - Centre de Radiothérapie et d'Oncologie
  • Albi, France
    • Clinique Claude Bernard
  • Amiens, France
    • Clinique de l'Europe
  • Angers, France
    • CHU d'Angers
  • Antony, France
    • Hopital Prive d'Antony
  • Aulnay-Sous-Bois, France
    • CHIC
  • Auxerre, France, 89011
    • Auxerre - CH
  • Avignon, France
    • CH d'Avignon
  • Bayonne, France
    • CH de la Côte Basque
  • Besancon, France, 25000
    • CHU Besancon - Pneumologie
  • Blois, France, 41016
    • Blois - CH
  • Bobigny, France
    • CHU Avicenne
  • Boulogne, France
    • Hôpital Ambroise Paré - Pneumologie
  • Bourg en Bresse, France
    • Hôpital Fleyriat
  • Briançon, France
    • Hôpital de Briançon
  • Béziers, France
    • CH de Béziers
  • Caen, France
    • CHU côte de Nacre
  • Cahors, France, 46000
    • Cahors - CH
  • Cannes, France
    • CH de Cannes
  • Chambray Les Tours, France, 37170
    • Chambray Les Tours - Clinique Léonard de Vinci
  • Chartres, France
    • CH de Chartres Hôpital Louis Pasteur
  • Chevilly-Larue, France, 94669
    • Chevilly-Larue - CH
  • Cholet, France
    • Hôpital de Cholet - Pneumologie
  • Clamart, France, 92140
    • Hôpital Percy-Armées - Pneumologie
  • Colmar, France
    • Hopital PASTEUR
  • Cornebarrieu, France
    • Clinique des Cèdres
  • Créteil, France, 94000
    • Créteil - CHI
  • Dax, France, 40107
    • Dax - CH
  • Denain, France
    • Denain - CH
  • Dijon, France, 21000
    • Dijon - CAC
  • Dijon, France, 63000
    • Dijon - CHU
  • Draguignan, France, 83300
    • Draguignan - CH
  • Dreux, France
    • CH de Dreux
  • Elbeuf, France
    • Elbeuf - CH
  • Epinal, France, 88021
    • Epinal - CH
  • Ermont, France
    • Ermont - Clinique Claude Bernard
  • Evreux, France
    • Evreux - CH
  • Flers, France
    • Flers - CH
  • Gap, France
    • CHICAS Site de Gap
  • Grenoble, France
    • CHRU Grenoble
  • Helfaut, France, 62570
    • Saint Omer - CHI
  • Jonzac, France, 17500
    • Jonzac - CH
  • La Roche Sur Yon, France, 85925
    • La Roche Sur Yon - CH
  • Le Havre, France, 76700
    • Le Havre - HPE
  • Le Mans, France, 72000
    • Le Mans - Centre Hospitalier
  • Le Mans, France
    • Le Mans - Clinique Victor Hugo
  • Lens, France
    • CH Dr Schaffner de Lens
  • Lille, France, 59000
    • CHU (Hôpital Calmette) - Pneumologie
  • Lille, France, 59000
    • Lille - Hôpital Calmette
  • Limoges, France, 87042
    • Limoges - Hôpital du Cluzeau
  • Liévin, France, 62806
    • Liévin - polyclinique de Riaumont
  • Longjumeau, France
    • CH de Longjumeau
  • Lorient, France
    • Lorient - CHBS
  • Lormont, France
    • Clinique des 4 Pavillons
  • Lyon, France
    • Lyon - Hôpital Louis Pradel (Pneumologie)
  • Lyon, France
    • Hopital de La Croix Rousse
  • Lyon, France, 69003
    • Lyon - Clinique Mutualiste
  • Lyon, France
    • Clinique Mutualiste Eugène André
  • Lyon, France
    • HIA Desgenettes
  • Mantes La Jolie, France, 78200
    • Mantes La Jolie - CH
  • Marseille, France, 13000
    • Marseille - Hôpital Sainte Marguerite
  • Marseille, France
    • Marseille - CRLCC
  • Maubeuge, France
    • Polyclinique du Parc
  • Meaux, France, 77100
    • Meaux - CH
  • Metz, France, 57000
    • Metz - CHR
  • Metz, France, 57000
    • Metz - Clinique Claude Bernard
  • Metz, France
    • Metz - Belle Isle
  • Mont de Marsan, France, 40000
    • Mont de Marsan - CH
  • Montpellier, France, 34295
    • Montpellier - CHRU
  • Montpellier, France, 34070
    • Montpellier - Clinique Clémentville
  • Moulins, France, 03000
    • Moulins - CH
  • Mulhouse, France, 68000
    • Mulhouse - CH
  • Nancy, France
    • Chu Nancy
  • Nancy, France
    • Nancy - Polyclinique Gentilly
  • Nanterre, France, 92014
    • Nanterre - CH
  • Nantes, France, 44805
    • Nantes - Centre René Gauducheau
  • Nantes, France
    • Hopital Laennec - CHU de Nantes
  • Narbonne, France
    • Narbonne - Polyclinique Le Languedoc
  • Neuilly, France, 92200
    • Neuilly - Hôpital Américain de Paris
  • Nevers, France, 58033
    • Nevers - CH
  • Nice, France, 06000
    • Nice - CAC
  • Nîmes, France, 30900
    • Nîmes - Clinique Valdegour
  • Nîmes, France
    • CHU
  • Orléans, France, 45000
    • Orléans - CH
  • Paris, France, 75000
    • Paris - Saint Louis
  • Paris, France
    • Hopital Bichat - Claude - Bernard
  • Paris, France
    • Hopital Europeen Georges Pompidou
  • Paris, France
    • Paris - Curie
  • Paris, France
    • Hopital Tenon
  • Paris, France, 75012
    • Paris - hôpital Saint-Antoine
  • Paris, France
    • GH Paris Saint-Joseph
  • Paris, France
    • Hôpital du Val de Grâce
  • Pau, France, 64046
    • Pau - CH
  • Perpignan, France, 66046
    • Perpignan - Ch
  • Perpignan, France, 66000
    • Perpignan - Centre Catalan d'Oncologie
  • Pierre Bénite, France, 69495
    • Lyon Sud
  • Poitiers, France
    • CHU
  • Pontoise, France
    • Pontoise - CH
  • Périgueux, France
    • CH de Périgueux
  • Reims, France, 51092
    • Reims - CHU
  • Reims, France
    • Reims - CRLCC
  • Rennes, France, 35033
    • Rennes - CHU
  • Roanne, France
    • CHG de Roanne
  • Rodez, France, 12021
    • Rodez - CH
  • Roncq, France, 59223
    • Roncq - Clinique Saint-Roch
  • Roubaix, France, 59100
    • Roubaix - CH
  • Rouen, France, 76000
    • Rouen - CHU
  • Rouen, France
    • Centre Frédéric JOLIOT
  • Saint Brieuc, France, 22000
    • Saint Brieuc - CHG
  • Saint Nazaire, France, 44600
    • Saint Nazaire - Centre Etienne Dolet
  • Saint Priest en Jarez, France, 42270
    • Saint Priest en Jarez - ICL
  • Saint Quentin, France, 02100
    • Saint Quentin - CH
  • Saint-Malo, France, 35403
    • Saint-Malo - CH
  • Saint-Nazaire, France
    • Saint-Nazaire - CH
  • Saverne, France
    • Saverne - CH
  • Senlis, France, 60300
    • Senlis - CH
  • Strasbourg, France, 63000
    • Strasbourg - NHC
  • Suresnes, France, 92151
    • Suresnes - Hopital Foch
  • Thonon les bains, France, 74200
    • Thonon les bains
  • Toulon, France, 83000
    • Toulon - CHI
  • Toulon, France, 83000
    • Toulon - HIA
  • Toulouse, France
    • Toulouse - CHU Larrey
  • Toulouse, France
    • Toulouse - Clinique Pasteur
  • Toulouse, France
    • Clinique Saint Jean du Languedoc
  • Tours, France, 37000
    • Tours - CHU
  • Troyes, France, 10000
    • Troyes - CH
  • Valenciennes, France, 59304
    • Valenciennes - Clinique
  • Verdun, France
    • Verdun - CHG
  • Vesoul, France, 70000
    • Vesoul - CHI
  • Vesoul, France
    • CHI de la Haute-Saône - Pneumologie
  • Vienne, France, 38200
    • Vienne - CH
  • Villejuif, France, 94800
    • Villejuif - Institut Gustave Roussy
  • Vénissieux, France
    • Clinique Mutualiste Les Portes du Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced non-small cell cancer

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Histology other than NSLC

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with advanced lung cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EGF-R gene mutation in nationwide cohort	Number of patients with EGF-R gene mutation	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
K-RAS gene mutation in nationwide cohort	Number of patients with K-RAS gene mutation	1 year
EML4-ALK translocation in nationwide cohort	Number of patients with EML4-ALK translocation	1 year
BRAF gene mutation in nationwide cohort	Number of patients with BRAF gene mutation	1 year
HER2 gene mutation in nationwide cohort	Number of patients with HER2 gene mutation	1 year
PI3K gene mutation in nationwide cohort	Number of patients with PI3K gene mutation	1 year

Collaborators and Investigators

• Sponsor: Intergroupe Francophone de Cancerologie Thoracique
• Investigators: Principal Investigator: Fabrice Barlesi, PhD, MD, IFCT, Aix Marseille Université / Assistance Publique Hôpitaux de Marseille

Publications and helpful links

General Publications

• Barlesi F, Mazieres J, Merlio JP, Debieuvre D, Mosser J, Lena H, Ouafik L, Besse B, Rouquette I, Westeel V, Escande F, Monnet I, Lemoine A, Veillon R, Blons H, Audigier-Valette C, Bringuier PP, Lamy R, Beau-Faller M, Pujol JL, Sabourin JC, Penault-Llorca F, Denis MG, Lantuejoul S, Morin F, Tran Q, Missy P, Langlais A, Milleron B, Cadranel J, Soria JC, Zalcman G; Biomarkers France contributors. Routine molecular profiling of patients with advanced non-small-cell lung cancer: results of a 1-year nationwide programme of the French Cooperative Thoracic Intergroup (IFCT). Lancet. 2016 Apr 2;387(10026):1415-1426. doi: 10.1016/S0140-6736(16)00004-0. Epub 2016 Jan 15.
• Blons H, Oudart JB, Merlio JP, Debieuvre D, de Fraipont F, Audigier-Valette C, Escande F, Hominal S, Bringuier PP, Fraboulet-Moreau S, Ouafik L, Moro-Sibilot D, Lemoine A, Langlais A, Missy P, Morin F, Souquet PJ, Barlesi F, Cadranel J, Beau-Faller M; French Cooperative Thoracic Intergroup (IFCT). PTEN, ATM, IDH1 mutations and MAPK pathway activation as modulators of PFS and OS in patients treated by first line EGFR TKI, an ancillary study of the French Cooperative Thoracic Intergroup (IFCT) Biomarkers France project. Lung Cancer. 2021 Jan;151:69-75. doi: 10.1016/j.lungcan.2020.11.008. Epub 2020 Nov 13.
• Beau-Faller M, Pencreach E, Leduc C, Blons H, Merlio JP, Bringuier PP, de Fraipont F, Escande F, Lemoine A, Ouafik L, Denis M, Hofman P, Lacave R, Melaabi S, Langlais A, Missy P, Morin F, Moro-Sibilot D, Barlesi F, Cadranel J; French Cooperative Thoracic Intergroup (IFCT). Independent prognostic value of ultra-sensitive quantification of tumor pre-treatment T790M subclones in EGFR mutated non-small cell lung cancer (NSCLC) treated by first/second generation TKI, depends on variant allele frequency (VAF): Results of the French cooperative thoracic intergroup (IFCT) biomarkers France project. Lung Cancer. 2020 Feb;140:19-26. doi: 10.1016/j.lungcan.2019.10.013. Epub 2019 Nov 15.
• Leduc C, Merlio JP, Besse B, Blons H, Debieuvre D, Bringuier PP, Monnet I, Rouquette I, Fraboulet-Moreau S, Lemoine A, Pouessel D, Mosser J, Vaylet F, Langlais A, Missy P, Morin F, Moro-Sibilot D, Cadranel J, Barlesi F, Beau-Faller M; French Cooperative Thoracic Intergroup (IFCT). Clinical and molecular characteristics of non-small-cell lung cancer (NSCLC) harboring EGFR mutation: results of the nationwide French Cooperative Thoracic Intergroup (IFCT) program. Ann Oncol. 2017 Nov 1;28(11):2715-2724. doi: 10.1093/annonc/mdx404.
• Kembou Nzale S, Weeks WB, Ouafik L, Rouquette I, Beau-Faller M, Lemoine A, Bringuier PP, Le Coroller Soriano AG, Barlesi F, Ventelou B. Inequity in access to personalized medicine in France: Evidences from analysis of geo variations in the access to molecular profiling among advanced non-small-cell lung cancer patients: Results from the IFCT Biomarkers France Study. PLoS One. 2020 Jul 1;15(7):e0234387. doi: 10.1371/journal.pone.0234387. eCollection 2020.
• Mordant P MD, PhD, Brosseau S, Milleron B, Santelmo N, Fraboulet-Moreau S, Besse B, Langlais A, Gossot D, Thomas PA, Pujol JL, Ricordel C, Madelaine J, Lamy R, Audigier-Valette C, Missy P, Blons H, Barlesi F, Westeel V; French Cooperative Thoracic Intergroup (IFCT). Outcome of Patients With Resected Early-Stage Non-small Cell Lung Cancer and EGFR Mutations: Results From the IFCT Biomarkers France Study. Clin Lung Cancer. 2023 Jan;24(1):1-10. doi: 10.1016/j.cllc.2022.08.013. Epub 2022 Aug 29.
• Guibert N, Barlesi F, Descourt R, Lena H, Besse B, Beau-Faller M, Mosser J, Pichon E, Merlio JP, Ouafik L, Guichard F, Mastroianni B, Moreau L, Wdowik A, Sabourin JC, Lemoine A, Missy P, Langlais A, Moro-Sibilot D, Mazieres J. Characteristics and Outcomes of Patients with Lung Cancer Harboring Multiple Molecular Alterations: Results from the IFCT Study Biomarkers France. J Thorac Oncol. 2017 Jun;12(6):963-973. doi: 10.1016/j.jtho.2017.02.001. Epub 2017 Feb 9.
• Couraud S, Barlesi F, Fontaine-Deraluelle C, Debieuvre D, Merlio JP, Moreau L, Beau-Faller M, Veillon R, Mosser J, Al Freijat F, Bringuier PP, Lena H, Ouafik L, Westeel V, Morel A, Audigier-Valette C, Missy P, Langlais A, Morin F, Souquet PJ, Planchard D; Biomarkers France Contributors. Clinical outcomes of non-small-cell lung cancer patients with BRAF mutations: results from the French Cooperative Thoracic Intergroup biomarkers France study. Eur J Cancer. 2019 Jul;116:86-97. doi: 10.1016/j.ejca.2019.04.016. Epub 2019 Jun 8.
• Ruppert AM, Beau-Faller M, Debieuvre D, Ouafik L, Westeel V, Rouquette I, Mazieres J, Bringuier PP, Monnet I, Escande F, Ricordel C, Merlio JP, Janicot H, Lemoine A, Foucher P, Poudenx M, Morin F, Langlais A, Souquet PJ, Barlesi F, Wislez M. Outcomes of Patients With Advanced NSCLC From the Intergroupe Francophone de Cancerologie Thoracique Biomarkers France Study by KRAS Mutation Subtypes. JTO Clin Res Rep. 2020 May 15;1(3):100052. doi: 10.1016/j.jtocrr.2020.100052. eCollection 2020 Sep.
• Tomasini P, Brosseau S, Mazieres J, Merlio JP, Beau-Faller M, Mosser J, Wislez M, Ouafik L, Besse B, Rouquette I, Debieuvre D, Escande F, Westeel V, Audigier-Valette C, Missy P, Langlais A, Morin F, Moro-Sibilot D, Zalcman G, Barlesi F. EGFR tyrosine kinase inhibitors versus chemotherapy in EGFR wild-type pre-treated advanced nonsmall cell lung cancer in daily practice. Eur Respir J. 2017 Aug 10;50(2):1700514. doi: 10.1183/13993003.00514-2017. Print 2017 Aug.

Helpful Links

• IFCT official website

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: August 1, 2012
• First Submitted That Met QC Criteria: October 2, 2012
• First Posted (Estimated): October 4, 2012

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: biomarkers; lung cancer; HER2; EGFR; KRAS; BRAF; PI3K; ALK; IFCT
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: Biomarkers-France

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO