NCT01700582

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17,664

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Shorter than P25 for all trials

Geographic Reach
1 country

133 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 4, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

August 1, 2012

Last Update Submit

July 20, 2023

Conditions

Keywords

lung cancerbiomarkersEGFRKRASALKHER2PI3KBRAFIFCT

Outcome Measures

Primary Outcomes (1)

  • EGF-R gene mutation in nationwide cohort

    Number of patients with EGF-R gene mutation

    1 Year

Secondary Outcomes (5)

  • K-RAS gene mutation in nationwide cohort

    1 year

  • EML4-ALK translocation in nationwide cohort

    1 year

  • BRAF gene mutation in nationwide cohort

    1 year

  • HER2 gene mutation in nationwide cohort

    1 year

  • PI3K gene mutation in nationwide cohort

    1 year

Study Arms (1)

Patients with advanced lung cancer

Patients with advanced lung cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with advanced non-small cell cancer

You may qualify if:

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

You may not qualify if:

  • \- Histology other than NSLC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (133)

Clinique Calabet - Centre de Radiothérapie et d'Oncologie

Agen, France

Location

Clinique Claude Bernard

Albi, France

Location

Clinique de l'Europe

Amiens, France

Location

CHU d'Angers

Angers, France

Location

Hôpital Privé d'Antony

Antony, France

Location

CHIC

Aulnay-sous-Bois, France

Location

Auxerre - CH

Auxerre, 89011, France

Location

CH d'Avignon

Avignon, France

Location

CH de la Côte Basque

Bayonne, France

Location

CHU Besancon - Pneumologie

Besançon, 25000, France

Location

CH de Béziers

Béziers, France

Location

Blois - CH

Blois, 41016, France

Location

CHU Avicenne

Bobigny, France

Location

Hôpital Ambroise Paré - Pneumologie

Boulogne, France

Location

Hôpital Fleyriat

Bourg-en-Bresse, France

Location

Hôpital de Briançon

Briançon, France

Location

CHU Côte de Nâcre

Caen, France

Location

Cahors - CH

Cahors, 46000, France

Location

CH de Cannes

Cannes, France

Location

Chambray Les Tours - Clinique Léonard de Vinci

Chambray-lès-Tours, 37170, France

Location

CH de Chartres Hôpital Louis Pasteur

Chartres, France

Location

Chevilly-Larue - CH

Chevilly-Larue, 94669, France

Location

Hôpital de Cholet - Pneumologie

Cholet, France

Location

Hôpital Percy-Armées - Pneumologie

Clamart, 92140, France

Location

Hôpital Pasteur

Colmar, France

Location

Clinique des Cèdres

Cornebarrieu, France

Location

Créteil - CHI

Créteil, 94000, France

Location

Dax - CH

Dax, 40107, France

Location

Denain - CH

Denain, France

Location

Dijon - CAC

Dijon, 21000, France

Location

Dijon - CHU

Dijon, 63000, France

Location

Draguignan - CH

Draguignan, 83300, France

Location

CH de Dreux

Dreux, France

Location

Elbeuf - CH

Elbeuf, France

Location

Ermont - Clinique Claude Bernard

Ermont, France

Location

Epinal - CH

Épinal, 88021, France

Location

Evreux - CH

Évreux, France

Location

Flers - CH

Flers, France

Location

CHICAS Site de Gap

Gap, France

Location

CHRU Grenoble

Grenoble, France

Location

Saint Omer - CHI

Helfaut, 62570, France

Location

Jonzac - CH

Jonzac, 17500, France

Location

La Roche Sur Yon - CH

La Roche-sur-Yon, 85925, France

Location

Le Havre - HPE

Le Havre, 76700, France

Location

Le Mans - Centre Hospitalier

Le Mans, 72000, France

Location

Le Mans - Clinique Victor Hugo

Le Mans, France

Location

CH Dr Schaffner de Lens

Lens, France

Location

Liévin - polyclinique de Riaumont

Liévin, 62806, France

Location

CHU (Hôpital Calmette) - Pneumologie

Lille, 59000, France

Location

Lille - Hôpital Calmette

Lille, 59000, France

Location

Limoges - Hôpital du Cluzeau

Limoges, 87042, France

Location

CH de Longjumeau

Longjumeau, France

Location

Lorient - CHBS

Lorient, France

Location

Clinique des 4 Pavillons

Lormont, France

Location

Lyon - Clinique Mutualiste

Lyon, 69003, France

Location

Clinique Mutualiste Eugène André

Lyon, France

Location

HIA Desgenettes

Lyon, France

Location

Hôpital de la Croix Rousse

Lyon, France

Location

Lyon - Hôpital Louis Pradel (Pneumologie)

Lyon, France

Location

Mantes La Jolie - CH

Mantes-la-Jolie, 78200, France

Location

Marseille - Hôpital Sainte Marguerite

Marseille, 13000, France

Location

Marseille - CRLCC

Marseille, France

Location

Polyclinique du Parc

Maubeuge, France

Location

Meaux - CH

Meaux, 77100, France

Location

Metz - CHR

Metz, 57000, France

Location

Metz - Clinique Claude Bernard

Metz, 57000, France

Location

Metz - Belle Isle

Metz, France

Location

Mont de Marsan - CH

Mont-de-Marsan, 40000, France

Location

Montpellier - Clinique Clémentville

Montpellier, 34070, France

Location

Montpellier - CHRU

Montpellier, 34295, France

Location

Moulins - CH

Moulins, 03000, France

Location

Mulhouse - CH

Mulhouse, 68000, France

Location

CHU Nancy

Nancy, France

Location

Nancy - Polyclinique Gentilly

Nancy, France

Location

Nanterre - CH

Nanterre, 92014, France

Location

Nantes - Centre René Gauducheau

Nantes, 44805, France

Location

Hôpital Laënnec - CHU de Nantes

Nantes, France

Location

Narbonne - Polyclinique Le Languedoc

Narbonne, France

Location

Neuilly - Hôpital Américain de Paris

Neuilly, 92200, France

Location

Nevers - CH

Nevers, 58033, France

Location

Nice - CAC

Nice, 06000, France

Location

Nîmes - Clinique Valdegour

Nîmes, 30900, France

Location

CHU

Nîmes, France

Location

Orléans - CH

Orléans, 45000, France

Location

Paris - Saint Louis

Paris, 75000, France

Location

Paris - hôpital Saint-Antoine

Paris, 75012, France

Location

GH Paris Saint-Joseph

Paris, France

Location

Hôpital Bichat - Claude - Bernard

Paris, France

Location

Hôpital du Val de Grâce

Paris, France

Location

Hôpital Européen Georges Pompidou

Paris, France

Location

Hôpital Tenon

Paris, France

Location

Paris - Curie

Paris, France

Location

Pau - CH

Pau, 64046, France

Location

Perpignan - Centre Catalan d'Oncologie

Perpignan, 66000, France

Location

Perpignan - Ch

Perpignan, 66046, France

Location

CH de Périgueux

Périgueux, France

Location

Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU

Poitiers, France

Location

Pontoise - CH

Pontoise, France

Location

Reims - CHU

Reims, 51092, France

Location

Reims - CRLCC

Reims, France

Location

Rennes - CHU

Rennes, 35033, France

Location

CHG de Roanne

Roanne, France

Location

Rodez - CH

Rodez, 12021, France

Location

Roncq - Clinique Saint-Roch

Roncq, 59223, France

Location

Roubaix - CH

Roubaix, 59100, France

Location

Rouen - CHU

Rouen, 76000, France

Location

Centre Frederic Joliot

Rouen, France

Location

Saint Brieuc - CHG

Saint-Brieuc, 22000, France

Location

Saint Nazaire - Centre Etienne Dolet

Saint-Nazaire, 44600, France

Location

Saint-Nazaire - CH

Saint-Nazaire, France

Location

Saint Priest en Jarez - ICL

Saint-Priest-en-Jarez, 42270, France

Location

Saint Quentin - CH

Saint-Quentin, 02100, France

Location

Saverne - CH

Saverne, France

Location

Senlis - CH

Senlis, 60300, France

Location

Saint-Malo - CH

St-Malo, 35403, France

Location

Strasbourg - NHC

Strasbourg, 63000, France

Location

Suresnes - Hopital Foch

Suresnes, 92151, France

Location

Thonon les bains

Thonon-les-Bains, 74200, France

Location

Toulon - CHI

Toulon, 83000, France

Location

Toulon - HIA

Toulon, 83000, France

Location

Clinique Saint Jean du Languedoc

Toulouse, France

Location

Toulouse - CHU Larrey

Toulouse, France

Location

Toulouse - Clinique Pasteur

Toulouse, France

Location

Tours - CHU

Tours, 37000, France

Location

Troyes - CH

Troyes, 10000, France

Location

Valenciennes - Clinique

Valenciennes, 59304, France

Location

Verdun - CHG

Verdun, France

Location

Vesoul - CHI

Vesoul, 70000, France

Location

CHI de la Haute-Saône - Pneumologie

Vesoul, France

Location

Clinique Mutualiste Les Portes du Sud

Vénissieux, France

Location

Vienne - CH

Vienne, 38200, France

Location

Villejuif - Institut Gustave Roussy

Villejuif, 94800, France

Location

Related Publications (10)

  • 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.

    PMID: 33248711BACKGROUND
  • 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.

    PMID: 31841714BACKGROUND
  • 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.

    PMID: 28945865BACKGROUND
  • 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.

    PMID: 32609781BACKGROUND
  • 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.

    PMID: 36180314BACKGROUND
  • 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.

    PMID: 28189832BACKGROUND
  • 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.

    PMID: 31181537BACKGROUND
  • 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.

    PMID: 34589947BACKGROUND
  • 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.

    PMID: 28798090BACKGROUND
  • 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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Fabrice Barlesi, PhD, MD

    IFCT, Aix Marseille Université / Assistance Publique Hôpitaux de Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2012

First Posted

October 4, 2012

Study Start

April 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

July 21, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations