French National Observatory of the Patients With Non-small Cell Lung (NSCLC) and Molecular Testings
NCT ID: NCT01700582
Last Updated: 2023-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
17664 participants
OBSERVATIONAL
2012-04-30
2013-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
LIquid BIopsies in Patients Presenting Non-small Cell Lung Cancer
NCT02511288
Prediction of Response to Treatment With Immunotherapy + Chemotherapy in Non-Small Cell Lung Cancer
NCT04589013
Clinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients
NCT02622581
Cohort of Non-small Cell Lung Cancer With Mutation of the Nord Pas de Calais (CB(NPC)²)
NCT02448758
French Biological Observatory on Lung Cancer in Never Smokers
NCT01465854
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with advanced lung cancer
Patients with advanced lung cancer
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Biomarkers analysis on hospital platforms
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Intergroupe Francophone de Cancerologie Thoracique
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fabrice Barlesi, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
IFCT, Aix Marseille Université / Assistance Publique Hôpitaux de Marseille
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinique Calabet - Centre de Radiothérapie et d'Oncologie
Agen, , France
Clinique Claude Bernard
Albi, , France
Clinique de l'Europe
Amiens, , France
CHU d'Angers
Angers, , France
Hôpital Privé d'Antony
Antony, , France
CHIC
Aulnay-sous-Bois, , France
Auxerre - CH
Auxerre, , France
CH d'Avignon
Avignon, , France
CH de la Côte Basque
Bayonne, , France
CHU Besancon - Pneumologie
Besançon, , France
CH de Béziers
Béziers, , France
Blois - CH
Blois, , France
CHU Avicenne
Bobigny, , France
Hôpital Ambroise Paré - Pneumologie
Boulogne, , France
Hôpital Fleyriat
Bourg-en-Bresse, , France
Hôpital de Briançon
Briançon, , France
CHU Côte de Nâcre
Caen, , France
Cahors - CH
Cahors, , France
CH de Cannes
Cannes, , France
Chambray Les Tours - Clinique Léonard de Vinci
Chambray-lès-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
Dax - CH
Dax, , 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
Ermont - Clinique Claude Bernard
Ermont, , France
Epinal - CH
Épinal, , France
Evreux - CH
Évreux, , France
Flers - CH
Flers, , France
CHICAS Site de Gap
Gap, , France
CHRU Grenoble
Grenoble, , France
Saint Omer - CHI
Helfaut, , France
Jonzac - CH
Jonzac, , France
La Roche Sur Yon - CH
La Roche-sur-Yon, , 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
Liévin - polyclinique de Riaumont
Liévin, , France
CHU (Hôpital Calmette) - Pneumologie
Lille, , France
Lille - Hôpital Calmette
Lille, , France
Limoges - Hôpital du Cluzeau
Limoges, , 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
HIA Desgenettes
Lyon, , France
Hôpital de la Croix Rousse
Lyon, , France
Lyon - Hôpital Louis Pradel (Pneumologie)
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
Meaux - CH
Meaux, , 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
Montpellier - CHRU
Montpellier, , France
Moulins - CH
Moulins, , France
Mulhouse - CH
Mulhouse, , France
CHU Nancy
Nancy, , France
Nancy - Polyclinique Gentilly
Nancy, , France
Nanterre - CH
Nanterre, , France
Nantes - Centre René Gauducheau
Nantes, , France
Hôpital Laënnec - CHU de Nantes
Nantes, , France
Narbonne - Polyclinique Le Languedoc
Narbonne, , France
Neuilly - Hôpital Américain de Paris
Neuilly, , France
Nevers - CH
Nevers, , France
Nice - CAC
Nice, , France
Nîmes - Clinique Valdegour
Nîmes, , France
CHU
Nîmes, , France
Orléans - CH
Orléans, , France
Paris - Saint Louis
Paris, , France
Paris - hôpital Saint-Antoine
Paris, , France
GH Paris Saint-Joseph
Paris, , France
Hôpital Bichat - Claude - Bernard
Paris, , France
Hôpital du Val de Grâce
Paris, , France
Hôpital Européen Georges Pompidou
Paris, , France
Hôpital Tenon
Paris, , France
Paris - Curie
Paris, , France
Pau - CH
Pau, , France
Perpignan - Centre Catalan d'Oncologie
Perpignan, , France
Perpignan - Ch
Perpignan, , France
CH de Périgueux
Périgueux, , France
Lyon Sud
Pierre-Bénite, , France
CHU
Poitiers, , France
Pontoise - CH
Pontoise, , France
Reims - CHU
Reims, , 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
Centre Frederic Joliot
Rouen, , France
Saint Brieuc - CHG
Saint-Brieuc, , France
Saint Nazaire - Centre Etienne Dolet
Saint-Nazaire, , France
Saint-Nazaire - CH
Saint-Nazaire, , France
Saint Priest en Jarez - ICL
Saint-Priest-en-Jarez, , France
Saint Quentin - CH
Saint-Quentin, , France
Saverne - CH
Saverne, , France
Senlis - CH
Senlis, , France
Saint-Malo - CH
St-Malo, , France
Strasbourg - NHC
Strasbourg, , France
Suresnes - Hopital Foch
Suresnes, , France
Thonon les bains
Thonon-les-Bains, , France
Toulon - CHI
Toulon, , France
Toulon - HIA
Toulon, , France
Clinique Saint Jean du Languedoc
Toulouse, , France
Toulouse - CHU Larrey
Toulouse, , France
Toulouse - Clinique Pasteur
Toulouse, , France
Tours - CHU
Tours, , France
Troyes - CH
Troyes, , France
Valenciennes - Clinique
Valenciennes, , France
Verdun - CHG
Verdun, , France
Vesoul - CHI
Vesoul, , France
CHI de la Haute-Saône - Pneumologie
Vesoul, , France
Clinique Mutualiste Les Portes du Sud
Vénissieux, , France
Vienne - CH
Vienne, , France
Villejuif - Institut Gustave Roussy
Villejuif, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
IFCT official website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Biomarkers-France
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.