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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01700582
• Other study ID #: Biomarkers-France
• Status: Completed
• Start date: April 2012
• Est. completion date: April 2013

Study information

• Verified date: July 2023
• Source: Intergroupe Francophone de Cancerologie Thoracique
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 17664
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Advanced Non-small cell lung cancer (NSLC)

• Biomarkers analysis on hospital platforms

Exclusion Criteria:

• Histology other than NSLC

Related Conditions & MeSH terms

• ALK Gene Mutation
• BRAF Gene Mutation
• Carcinoma, Non-Small-Cell Lung
• KRAS Gene Mutation

Locations

Country	Name	City	State
France	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	Besancon
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 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	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	Epinal - CH	Epinal
France	Ermont - Clinique Claude Bernard	Ermont
France	Evreux - CH	Evreux
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	Clinique Mutualiste Eugène André	Lyon
France	HIA Desgenettes	Lyon
France	Hôpital de la Croix Rousse	Lyon
France	Lyon - Clinique Mutualiste	Lyon
France	Lyon - Hôpital Louis Pradel (Pneumologie)	Lyon
France	Mantes La Jolie - CH	Mantes La Jolie
France	Marseille - CRLCC	Marseille
France	Marseille - Hôpital Sainte Marguerite	Marseille
France	Polyclinique du Parc	Maubeuge
France	Meaux - CH	Meaux
France	Metz - Belle Isle	Metz
France	Metz - CHR	Metz
France	Metz - Clinique Claude Bernard	Metz
France	Mont de Marsan - CH	Mont de Marsan
France	Montpellier - CHRU	Montpellier
France	Montpellier - Clinique Clémentville	Montpellier
France	Moulins - CH	Moulins
France	Mulhouse - CH	Mulhouse
France	CHU Nancy	Nancy
France	Nancy - Polyclinique Gentilly	Nancy
France	Nanterre - CH	Nanterre
France	Hôpital Laënnec - CHU de Nantes	Nantes
France	Nantes - Centre René Gauducheau	Nantes
France	Narbonne - Polyclinique Le Languedoc	Narbonne
France	Neuilly - Hôpital Américain de Paris	Neuilly
France	Nevers - CH	Nevers
France	Nice - CAC	Nice
France	CHU	Nîmes
France	Nîmes - Clinique Valdegour	Nîmes
France	Orléans - CH	Orléans
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	Paris - hôpital Saint-Antoine	Paris
France	Paris - Saint Louis	Paris
France	Pau - CH	Pau
France	CH de Périgueux	Périgueux
France	Perpignan - Centre Catalan d'Oncologie	Perpignan
France	Perpignan - Ch	Perpignan
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	Centre Frederic Joliot	Rouen
France	Rouen - CHU	Rouen
France	Saint Brieuc - CHG	Saint Brieuc
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	Saint-Malo - CH	Saint-Malo
France	Saint-Nazaire - CH	Saint-Nazaire
France	Saverne - CH	Saverne
France	Senlis - CH	Senlis
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	Clinique Mutualiste Les Portes du Sud	Vénissieux
France	Verdun - CHG	Verdun
France	CHI de la Haute-Saône - Pneumologie	Vesoul
France	Vesoul - CHI	Vesoul
France	Vienne - CH	Vienne
France	Villejuif - Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Intergroupe Francophone de Cancerologie Thoracique

Country where clinical trial is conducted

France, 

References & Publications (10)

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EGF-R gene mutation in nationwide cohort	Number of patients with EGF-R gene mutation	1 Year
Secondary	K-RAS gene mutation in nationwide cohort	Number of patients with K-RAS gene mutation	1 year
Secondary	EML4-ALK translocation in nationwide cohort	Number of patients with EML4-ALK translocation	1 year
Secondary	BRAF gene mutation in nationwide cohort	Number of patients with BRAF gene mutation	1 year
Secondary	HER2 gene mutation in nationwide cohort	Number of patients with HER2 gene mutation	1 year
Secondary	PI3K gene mutation in nationwide cohort	Number of patients with PI3K gene mutation	1 year

External Links

•   IFCT official website