French Biological Observatory on Lung Cancer in Never Smokers

Lung Cancer Clinical Trial

— BioCAST  

Official title:

French Biological Observatory on Lung Cancer in Never Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01465854
• Other study ID #: IFCT-1002 BioCAST
• Status: Completed
• Start date: November 2011
• Est. completion date: January 2013

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 422
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
France	Centre Hospitalier du Pays d'Aix	Aix-en-Provence
France	CHD Castelluccio	Ajaccio
France	Clinique Claude Bernard	Albi
France	CHU d'Angers	Angers
France	CHI Annemasse-Bonneville	Annemasse
France	CH Annonay	Annonay
France	Hôpital Privé d'Antony	Antony
France	CHIC	Aulnay-Sous-Bois
France	CH de la Côte Basque	Bayonne
France	CHU Besançon	Besançon
France	Hôpital Ambroise Paré - Pneumologie	Boulogne
France	Hôpital Fleyriat	Bourg en Bresse
France	CH Jacques-Cœur - Pneumologie	Bourges
France	CH Pierre Oudot	Bourgoin-Jallieu
France	HCL Hôpital Louis Pradel	Bron
France	Centre François Baclesse	Caen
France	CHU Côte de Nâcre	Caen
France	CH Cahors	Cahors
France	CH de Cannes	Cannes
France	Centre Médical Nicolas de Pontoux	Châlon-sur-Saône
France	CH de Châlons-en-Champagne	Châlons-en-Champagne
France	CH Chambery	Chambery
France	CH de Chartres Hôpital Louis Pasteur	Chartres
France	CH de Chauny	Chauny
France	Hôpital de Cholet - Pneumologie	Cholet
France	HIA Percy - Pneumologie	Clamart
France	Hôpitral Gabriel Montpied - Pneumologie	Clermont-Ferrand
France	Hôpital Pasteur	Colmar
France	CH Compiègne - Pneumologie	Compiègne
France	CHI Créteil	Créteil
France	CH de Dax	Dax
France	Cabinet privé	Dijon
France	Centre d'Oncologie du Parc	Dijon
France	Centre Georges François Leclerc	Dijon
France	CHU Hôpital du Bocage	Dijon
France	CHRU Grenoble	Grenoble
France	CH Région Saint-Omer	Helfaut
France	CH Lagny-sur-Marne	Lagny-sur-Marne
France	CH de Versailles	Le Chesnay
France	CH du Mans	Le Mans
France	Centre Oscar Lambret	Lille
France	Hôpital Calmette	Lille
France	CH de Longjumeau	Longjumeau
France	CH Lyon Sud - Pneumologie	Lyon
France	CH Saint Joseph Saint Luc	Lyon
France	Clinique Mutualiste Eugène André	Lyon
France	HIA Desgenettes	Lyon
France	Hôpital de la Croix Rousse	Lyon
France	CH de Macon	Macon
France	Hôpital Ambroise Paré	Marseille
France	Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques	Marseille
France	Polyclinique du Parc	Maubeuge
France	CHR Metz Thionville	Metz
France	CH de Mont-De-Marsan	Mont-De-Marsan
France	CH Montélimar	Montélimar
France	CH de Mulhouse	Mulhouse
France	CHU Nancy	Nancy
France	Hôpital Laënnec - CHU de Nantes	Nantes
France	CH Nevers	Nevers
France	Centre Antoine Lacassagne	Nice
France	CHR d'Orléans La Source	Orléans
France	GH Paris Saint-Joseph	Paris
France	Hôpital Bichat - Claude - Bernard	Paris
France	Hôpital Saint Antoine	Paris
France	Hôpital Tenon	Paris
France	CH de Rambouillet	Rambouillet
France	Institut Jean Godinot	Reims
France	CHU Charles Nicolle	Rouen
France	Institut de Cancérologie de la Loire	Saint Priest en Jarez
France	CH de Saint-Brieuc	Saint-Brieuc
France	CHU Strasbourg	Strasbourg
France	Hôpital Foch	Suresnes
France	Hôpitaux du Léman - Pneumologie et Maladies Infectieuses	Thonon-les-Bains
France	Hôpital Font-Pré - Pneumologie	Toulon
France	Clinique Pasteur	Toulouse
France	Clinique Saint Jean du Languedoc	Toulouse
France	Hôpital Larrey - Pneumologie	Toulouse
France	CHU Tours - Pneumologie	Tours
France	CH Valence	Valence
France	Clinique Mutualiste Les Portes du Sud	Vénissieux
France	CHI de la Haute-Saône - Pneumologie	Vesoul
France	CH de Villefranche - Pneumologie	Villefranche

Sponsors (1)

Lead Sponsor	Collaborator
Intergroupe Francophone de Cancerologie Thoracique

Country where clinical trial is conducted

France, 

References & Publications (6)

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 — View 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 Resp — View 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 Cooperativ — View 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, Olivie — View 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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of EGFR mutations in never smokers with newly diagnosed non-small-cell lung cancer (NSCLC)		November 2011 to January 2013

External Links

•   Official website