Carcinoma, Non-Small-Cell LungNCT01700582
French National Observatory of the Patients With Non-small Cell Lung (NSCLC) and Molecular Testings
An observational study of Carcinoma, Non-Small-Cell Lung and ALK Gene Mutation, run by Intergroupe Francophone de Cancerologie Thoracique at 133 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, ALK Gene Mutation, KRAS Gene Mutation
- How many people
- 17,664 participants
- Where
- 133 sitesFrance
- Study dates
- Apr 2012to Apr 2013
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced non-small cell cancer
Who may be able to join
- Advanced Non-small cell lung cancer (NSLC)
- Biomarkers analysis on hospital platforms
Who cannot join
- Histology other than NSLC
Trial locations and contacts
133 sites in 1 country.
133 sites in 1 country
France133 sites
Clinique Calabet - Centre de Radiothérapie et d'Oncologie
Agen
Clinique Claude Bernard
Albi
Clinique de l'Europe
Amiens
CHU d'Angers
Angers
Hôpital Privé d'Antony
Antony
CHIC
Aulnay-sous-Bois
Auxerre - CH
Auxerre, 89011
CH d'Avignon
Avignon
CH de la Côte Basque
Bayonne
CHU Besancon - Pneumologie
Besançon, 25000
CH de Béziers
Béziers
Blois - CH
Blois, 41016
CHU Avicenne
Bobigny
Hôpital Ambroise Paré - Pneumologie
Boulogne
Hôpital Fleyriat
Bourg-en-Bresse
Hôpital de Briançon
Briançon
CHU Côte de Nâcre
Caen
Cahors - CH
Cahors, 46000
CH de Cannes
Cannes
Chambray Les Tours - Clinique Léonard de Vinci
Chambray-lès-Tours, 37170
CH de Chartres Hôpital Louis Pasteur
Chartres
Chevilly-Larue - CH
Chevilly-Larue, 94669
Hôpital de Cholet - Pneumologie
Cholet
Hôpital Percy-Armées - Pneumologie
Clamart, 92140
Hôpital Pasteur
Colmar
Clinique des Cèdres
Cornebarrieu
Créteil - CHI
Créteil, 94000
Dax - CH
Dax, 40107
Denain - CH
Denain
Dijon - CAC
Dijon, 21000
Dijon - CHU
Dijon, 63000
Draguignan - CH
Draguignan, 83300
CH de Dreux
Dreux
Elbeuf - CH
Elbeuf
Epinal - CH
Épinal, 88021
Ermont - Clinique Claude Bernard
Ermont
Evreux - CH
Évreux
Flers - CH
Flers
CHICAS Site de Gap
Gap
CHRU Grenoble
Grenoble
Saint Omer - CHI
Helfaut, 62570
Jonzac - CH
Jonzac, 17500
La Roche Sur Yon - CH
La Roche-sur-Yon, 85925
Le Havre - HPE
Le Havre, 76700
Le Mans - Centre Hospitalier
Le Mans, 72000
Le Mans - Clinique Victor Hugo
Le Mans
CH Dr Schaffner de Lens
Lens
Liévin - polyclinique de Riaumont
Liévin, 62806
CHU (Hôpital Calmette) - Pneumologie
Lille, 59000
Lille - Hôpital Calmette
Lille, 59000
Limoges - Hôpital du Cluzeau
Limoges, 87042
CH de Longjumeau
Longjumeau
Lorient - CHBS
Lorient
Clinique des 4 Pavillons
Lormont
Lyon - Clinique Mutualiste
Lyon, 69003
Clinique Mutualiste Eugène André
Lyon
HIA Desgenettes
Lyon
Hôpital de la Croix Rousse
Lyon
Lyon - Hôpital Louis Pradel (Pneumologie)
Lyon
Mantes La Jolie - CH
Mantes-la-Jolie, 78200
Marseille - Hôpital Sainte Marguerite
Marseille, 13000
Marseille - CRLCC
Marseille
Polyclinique du Parc
Maubeuge
Meaux - CH
Meaux, 77100
Metz - CHR
Metz, 57000
Metz - Clinique Claude Bernard
Metz, 57000
Metz - Belle Isle
Metz
Mont de Marsan - CH
Mont-de-Marsan, 40000
Montpellier - Clinique Clémentville
Montpellier, 34070
Montpellier - CHRU
Montpellier, 34295
Moulins - CH
Moulins, 03000
Mulhouse - CH
Mulhouse, 68000
CHU Nancy
Nancy
Nancy - Polyclinique Gentilly
Nancy
Nanterre - CH
Nanterre, 92014
Nantes - Centre René Gauducheau
Nantes, 44805
Hôpital Laënnec - CHU de Nantes
Nantes
Narbonne - Polyclinique Le Languedoc
Narbonne
Neuilly - Hôpital Américain de Paris
Neuilly, 92200
Nevers - CH
Nevers, 58033
Nice - CAC
Nice, 06000
Nîmes - Clinique Valdegour
Nîmes, 30900
CHU
Nîmes
Orléans - CH
Orléans, 45000
Paris - Saint Louis
Paris, 75000
Paris - hôpital Saint-Antoine
Paris, 75012
GH Paris Saint-Joseph
Paris
Hôpital Bichat - Claude - Bernard
Paris
Hôpital du Val de Grâce
Paris
Hôpital Européen Georges Pompidou
Paris
Hôpital Tenon
Paris
Paris - Curie
Paris
Pau - CH
Pau, 64046
CH de Périgueux
Périgueux
Perpignan - Centre Catalan d'Oncologie
Perpignan, 66000
Perpignan - Ch
Perpignan, 66046
Lyon Sud
Pierre-Bénite, 69495
CHU
Poitiers
Pontoise - CH
Pontoise
Reims - CHU
Reims, 51092
Reims - CRLCC
Reims
Rennes - CHU
Rennes, 35033
CHG de Roanne
Roanne
Rodez - CH
Rodez, 12021
Roncq - Clinique Saint-Roch
Roncq, 59223
Roubaix - CH
Roubaix, 59100
Rouen - CHU
Rouen, 76000
Centre Frederic Joliot
Rouen
Saint Brieuc - CHG
Saint-Brieuc, 22000
Saint Nazaire - Centre Etienne Dolet
Saint-Nazaire, 44600
Saint-Nazaire - CH
Saint-Nazaire
Saint Priest en Jarez - ICL
Saint-Priest-en-Jarez, 42270
Saint Quentin - CH
Saint-Quentin, 02100
Saverne - CH
Saverne
Senlis - CH
Senlis, 60300
Saint-Malo - CH
St-Malo, 35403
Strasbourg - NHC
Strasbourg, 63000
Suresnes - Hopital Foch
Suresnes, 92151
Thonon les bains
Thonon-les-Bains, 74200
Toulon - CHI
Toulon, 83000
Toulon - HIA
Toulon, 83000
Clinique Saint Jean du Languedoc
Toulouse
Toulouse - CHU Larrey
Toulouse
Toulouse - Clinique Pasteur
Toulouse
Tours - CHU
Tours, 37000
Troyes - CH
Troyes, 10000
Valenciennes - Clinique
Valenciennes, 59304
Clinique Mutualiste Les Portes du Sud
Vénissieux
Verdun - CHG
Verdun
Vesoul - CHI
Vesoul, 70000
CHI de la Haute-Saône - Pneumologie
Vesoul
Vienne - CH
Vienne, 38200
Villejuif - Institut Gustave Roussy
Villejuif, 94800
About this study
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.
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).
Read the 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.
- Keywords
- lung cancer, biomarkers, EGFR, KRAS, ALK, HER2, PI3K, BRAF, IFCT
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with advanced lung cancer | Patients with advanced lung cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
EGF-R gene mutation in nationwide cohort
Number of patients with EGF-R gene mutation
Measured: 1 Year
Secondary outcomes (5)
K-RAS gene mutation in nationwide cohort
Number of patients with K-RAS gene mutation
Measured: 1 year
EML4-ALK translocation in nationwide cohort
Number of patients with EML4-ALK translocation
Measured: 1 year
BRAF gene mutation in nationwide cohort
Number of patients with BRAF gene mutation
Measured: 1 year
HER2 gene mutation in nationwide cohort
Number of patients with HER2 gene mutation
Measured: 1 year
PI3K gene mutation in nationwide cohort
Number of patients with PI3K gene mutation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17,664 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice Barlesi, PhD, MD, Principal investigator, IFCT, Aix Marseille Université / Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700582
- Sponsor's protocol ID
- Biomarkers-France
- Status last verified
- Jul 2023
- First submitted
- 1 Aug 2012
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33248711Beau-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.
PubMed 31841714Leduc 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.
PubMed 28945865Kembou 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.
PubMed 32609781Mordant 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.
PubMed 36180314Guibert 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.
PubMed 28189832Couraud 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.
PubMed 31181537Ruppert 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.
PubMed 34589947Tomasini 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.
PubMed 28798090Barlesi 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.
PubMed 26777916