Clinical trial NCT01465854: French Biological Observatory on Lung Cancer in Never Smokers
Official title: French Biological Observatory on Lung Cancer in Never Smokers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: lung cancer
smoking
molecular epidemiology
genetic polymorphism
risk factors
never smokers
histologically/cytologically confirmed
IFCT
Lead sponsor: Intergroupe Francophone de Cancerologie Thoracique
Sponsor class: OTHER
First posted: 2011-11-06
Enrollment: 422
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Never smokers with newly diagnosed lung cancer

Brief summary: Lung cancer in non-smokers (LCINS) is an increasing public health problem. The BioCAST (IFCT-1002) study, promoted by Intergroupe Francophone de Cancérologie Thoracique (IFCT), focuses on this entity. It is a national, multicentric, prospective epidemiological study. Main objective is to describe the clinical and molecular epidemiology of LCINS in a large French cohort composed by cases newly diagnosed in participating centres (around to 1000 patients expected). The clinical component of the study is based on collecting data directly from the patient through a standardized questionnaire during a telephone interview with a health professional. The biologic component includes a blood sample collection. A large genomic-wide association study and an epigenetic study are also planned. BioCAST hopes to provide concrete answers to clinicians and patients questions about this new and frequent entity.

Detailed description: According to WHO, 25% of lung cancer worldwide occurs in lifelong never smokers. Lung cancer in never smokers (LCINS) shows many clinical, epidemiological, molecular and genomic differences comparing to tobacco-related neoplasm. So, it is now considered as a separate entity. LCINS particularly occurs in women and Asian. They are mainly adenocarcinoma. Known risk factors are occupational exposure, environmental tobacco smoking, familial history of cancer, personal medical history of lung disease or environmental causes. LCINS carries more frequently molecular abnormalities leading to efficacy of targeted therapies (EGFR mutation, EML4-ALK inversion, less frequent mutations of KRAS ...). However, most data come from retrospectives studies, subgroups analysis and/or from Asian cohort even though it is a disease with a significant geographic variability. Finally, few studies focus on correlations between risk factors and molecular or genomic abnormalities.

For these reasons and considering that LCINS is an increasing public health problem, IFCT (Intergroupe Francophone de Cancérologie Thoracique) states to promote the BioCAST study (IFCT-1002). It is a national, multicentric, prospective epidemiological study. Main objective is to describe the clinical and molecular epidemiology of LCINS in a French population composed by all cases newly diagnosed in participating centres (500 to 1500 patients expected). BioCAST include a clinical and a biological part. The clinical component is based on collecting data directly from the patient through a standardized questionnaire during a telephone interview with a health professional. The biologic component includes a blood sample collection. A large genomic wide association study and an epigenetic study (including micro RNA study) are also planned. Other objectives are looking for correlations between clinical factors and molecular abnormalities; and looking for new oncogene in this specific population.

BioCAST hopes to provide concrete answers to clinicians and patients about this new and frequent entity.

Eligibility criteria: Inclusion Criteria:

* never smokers (i.e. who has smoked less than 100 cigarettes per lifetime)
* at least 18 years of age
* newly diagnosed lung cancer
* patient having access to a telephone
* french-speaking patient or patient who could be easily helped in his mother tongue during a phone interview
* signed informed consent

Exclusion Criteria:

* smokers
* chemotherapy already initiated at enrollment

Primary outcomes:
measure: Prevalence of EGFR mutations in never smokers with newly diagnosed non-small-cell lung cancer (NSCLC)
timeFrame: November 2011 to January 2013
Secondary outcomes:
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Centre Hospitalier du Pays d'Aix
city: Ajaccio
country: France
facility: CHD Castelluccio
city: Albi
country: France
facility: Clinique Claude Bernard
city: Angers
country: France
facility: CHU d'Angers
city: Annemasse
country: France
facility: CHI Annemasse-Bonneville
city: Annonay
country: France
facility: CH Annonay
city: Antony
country: France
facility: Hôpital Privé d'Antony
city: Aulnay-Sous-Bois
country: France
facility: CHIC
city: Bayonne
country: France
facility: CH de la Côte Basque
city: Besançon
country: France
facility: CHU Besançon
city: Boulogne
country: France
facility: Hôpital Ambroise Paré - Pneumologie
city: Bourg en Bresse
country: France
facility: Hôpital Fleyriat
city: Bourges
country: France
facility: CH Jacques-Cœur - Pneumologie
city: Bourgoin-Jallieu
country: France
facility: CH Pierre Oudot
city: Bron
country: France
facility: HCL Hôpital Louis Pradel
city: Caen
country: France
facility: Centre François Baclesse
city: Caen
country: France
facility: CHU Côte de Nâcre
city: Cahors
country: France
facility: CH Cahors
city: Cannes
country: France
facility: CH de Cannes
city: Chambery
country: France
facility: CH Chambery
city: Chartres
country: France
facility: CH de Chartres Hôpital Louis Pasteur
city: Chauny
country: France
facility: CH de Chauny
city: Cholet
country: France
facility: Hôpital de Cholet - Pneumologie
city: Châlon-sur-Saône
country: France
facility: Centre Médical Nicolas de Pontoux
city: Châlons-en-Champagne
country: France
facility: CH de Châlons-en-Champagne
city: Clamart
country: France
facility: HIA Percy - Pneumologie
city: Clermont-Ferrand
country: France
facility: Hôpitral Gabriel Montpied - Pneumologie
city: Colmar
country: France
facility: Hôpital Pasteur
city: Compiègne
country: France
facility: CH Compiègne - Pneumologie
city: Créteil
country: France
facility: CHI Créteil
city: Dax
country: France
facility: CH de Dax
city: Dijon
country: France
facility: Cabinet privé
city: Dijon
country: France
facility: Centre d'Oncologie du Parc
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Dijon
country: France
facility: CHU Hôpital du Bocage
city: Grenoble
country: France
facility: CHRU Grenoble
city: Helfaut
country: France
facility: CH Région Saint-Omer
city: Lagny-sur-Marne
country: France
facility: CH Lagny-sur-Marne
city: Le Chesnay
country: France
facility: CH de Versailles
city: Le Mans
country: France
facility: CH du Mans
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: Hôpital Calmette
city: Longjumeau
country: France
facility: CH de Longjumeau
city: Lyon
country: France
facility: CH Lyon Sud - Pneumologie
city: Lyon
country: France
facility: CH Saint Joseph Saint Luc
city: Lyon
country: France
facility: Clinique Mutualiste Eugène André
city: Lyon
country: France
facility: HIA Desgenettes
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Macon
country: France
facility: CH de Macon
city: Marseille
country: France
facility: Hôpital Ambroise Paré
city: Marseille
country: France
facility: Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
city: Maubeuge
country: France
facility: Polyclinique du Parc
city: Metz
country: France
facility: CHR Metz Thionville
city: Mont-De-Marsan
country: France
facility: CH de Mont-De-Marsan
city: Montélimar
country: France
facility: CH Montélimar
city: Mulhouse
country: France
facility: CH de Mulhouse
city: Nancy
country: France
facility: CHU Nancy
city: Nantes
country: France
facility: Hôpital Laënnec - CHU de Nantes
city: Nevers
country: France
facility: CH Nevers
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Orléans
country: France
facility: CHR d'Orléans La Source
city: Paris
country: France
facility: GH Paris Saint-Joseph
city: Paris
country: France
facility: Hôpital Bichat - Claude - Bernard
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Paris
country: France
facility: Hôpital Tenon
city: Rambouillet
country: France
facility: CH de Rambouillet
city: Reims
country: France
facility: Institut Jean Godinot
city: Rouen
country: France
facility: CHU Charles Nicolle
city: Saint Priest en Jarez
country: France
facility: Institut de Cancérologie de la Loire
city: Saint-Brieuc
country: France
facility: CH de Saint-Brieuc
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Suresnes
country: France
facility: Hôpital Foch
city: Thonon-les-Bains
country: France
facility: Hôpitaux du Léman - Pneumologie et Maladies Infectieuses
city: Toulon
country: France
facility: Hôpital Font-Pré - Pneumologie
city: Toulouse
country: France
facility: Clinique Pasteur
city: Toulouse
country: France
facility: Clinique Saint Jean du Languedoc
city: Toulouse
country: France
facility: Hôpital Larrey - Pneumologie
city: Tours
country: France
facility: CHU Tours - Pneumologie
city: Valence
country: France
facility: CH Valence
city: Vesoul
country: France
facility: CHI de la Haute-Saône - Pneumologie
city: Villefranche
country: France
facility: CH de Villefranche - Pneumologie
city: Vénissieux
country: France
facility: Clinique Mutualiste Les Portes du Sud
Study officials:
affiliation: Hospices Civils de Lyon, CH Lyon Sud, FRANCE
name: Sebastien COURAUD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Couraud S, Debieuvre D, Moreau L, Dumont P, Margery J, Quoix E, Duvert B, Cellerin L, Baize N, Taviot B, Coudurier M, Cadranel J, Missy P, Morin F, Mornex JF, Zalcman G, Souquet PJ; BioCAST/IFCT-1002 study investigators. No impact of passive smoke on the somatic profile of lung cancers in never-smokers. Eur Respir J. 2015 May;45(5):1415-25. doi: 10.1183/09031936.00097314. Epub 2015 Mar 5.
citation: Couraud S, Souquet PJ, Paris C, Do P, Doubre H, Pichon E, Dixmier A, Monnet I, Etienne-Mastroianni B, Vincent M, Tredaniel J, Perrichon M, Foucher P, Coudert B, Moro-Sibilot D, Dansin E, Labonne S, Missy P, Morin F, Blanche H, Zalcman G; French Cooperative Intergroup IFCT. BioCAST/IFCT-1002: epidemiological and molecular features of lung cancer in never-smokers. Eur Respir J. 2015 May;45(5):1403-14. doi: 10.1183/09031936.00097214. Epub 2015 Feb 5.
citation: Couraud S, Vaca-Paniagua F, Villar S, Oliver J, Schuster T, Blanche H, Girard N, Tredaniel J, Guilleminault L, Gervais R, Prim N, Vincent M, Margery J, Larive S, Foucher P, Duvert B, Vallee M, Le Calvez-Kelm F, McKay J, Missy P, Morin F, Zalcman G, Olivier M, Souquet PJ; BioCAST/IFCT-1002 investigators. Noninvasive diagnosis of actionable mutations by deep sequencing of circulating free DNA in lung cancer from never-smokers: a proof-of-concept study from BioCAST/IFCT-1002. Clin Cancer Res. 2014 Sep 1;20(17):4613-24. doi: 10.1158/1078-0432.CCR-13-3063. Epub 2014 Jul 10.
citation: Couraud S, Labonne S, Missy P, Morin F, Tran Q, Deroy A, Milleron B, Blanche H, Zalcman G, Souquet PJ; les membres du Groupe de travail << non-fumeurs de l'IFCT >>. [Lung cancer in never smokers: a French national cohort (BioCAST/IFCT-1002)]. Rev Mal Respir. 2013 Sep;30(7):576-83. doi: 10.1016/j.rmr.2013.03.006. Epub 2013 May 18. French.
citation: Fontaine-Delaruelle C, Mazieres J, Cadranel J, Mastroianni B, Dubos-Arvis C, Dumont P, Monnet I, Pichon E, Locatelli-Sanchez M, Dixmier A, Coudert B, Fraboulet S, Foucher P, Dansin E, Baize N, Vincent M, Missy P, Morin F, Moro-Sibilot D, Couraud S; IFCT10-02 BioCAST investigators. Somatic profile in lung cancers is associated to reproductive factors in never-smokers women: Results from the IFCT-1002 BioCAST study. Respir Med Res. 2020 Mar;77:58-66. doi: 10.1016/j.resmer.2020.01.003. Epub 2020 Jan 31.
citation: Paris C, Do P, Mastroianni B, Dixmier A, Dumont P, Pichon E, Chouaid C, Coudert B, Foucher P, Fraboulet S, Locatelli-Sanchez M, Baize N, Dansin E, Moreau L, Vincent M, Missy P, Morin F, Moro-Sibilot D, Couraud S; BioCAST/IFCT-1002 study investigators; to the BioCAST/IFCT- 1002 study. Association between lung cancer somatic mutations and occupational exposure in never-smokers. Eur Respir J. 2017 Oct 26;50(4):1700716. doi: 10.1183/13993003.00716-2017. Print 2017 Oct.