French Biological Observatory on Lung Cancer in Never Smokers

NCT ID: NCT01465854

Last Updated: 2023-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

422 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-01-31

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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LCINS

Never smokers with newly diagnosed lung cancer

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intergroupe Francophone de Cancerologie Thoracique

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sebastien COURAUD, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon, CH Lyon Sud, FRANCE

Locations

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Centre Hospitalier du Pays d'Aix

Aix-en-Provence, , France

Site Status

CHD Castelluccio

Ajaccio, , France

Site Status

Clinique Claude Bernard

Albi, , France

Site Status

CHU d'Angers

Angers, , France

Site Status

CHI Annemasse-Bonneville

Annemasse, , France

Site Status

CH Annonay

Annonay, , France

Site Status

Hôpital Privé d'Antony

Antony, , France

Site Status

CHIC

Aulnay-sous-Bois, , France

Site Status

CH de la Côte Basque

Bayonne, , France

Site Status

CHU Besançon

Besançon, , France

Site Status

Hôpital Ambroise Paré - Pneumologie

Boulogne, , France

Site Status

Hôpital Fleyriat

Bourg-en-Bresse, , France

Site Status

CH Jacques-Cœur - Pneumologie

Bourges, , France

Site Status

CH Pierre Oudot

Bourgoin, , France

Site Status

HCL Hôpital Louis Pradel

Bron, , France

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Centre François Baclesse

Caen, , France

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CHU Côte de Nâcre

Caen, , France

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CH Cahors

Cahors, , France

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CH de Cannes

Cannes, , France

Site Status

CH Chambery

Chambéry, , France

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CH de Chartres Hôpital Louis Pasteur

Chartres, , France

Site Status

CH de Chauny

Chauny, , France

Site Status

Centre Médical Nicolas de Pontoux

Châlon-sur-Saône, , France

Site Status

CH de Châlons-en-Champagne

Châlons-en-Champagne, , France

Site Status

Hôpital de Cholet - Pneumologie

Cholet, , France

Site Status

HIA Percy - Pneumologie

Clamart, , France

Site Status

Hôpitral Gabriel Montpied - Pneumologie

Clermont-Ferrand, , France

Site Status

Hôpital Pasteur

Colmar, , France

Site Status

CH Compiègne - Pneumologie

Compiègne, , France

Site Status

CHI Créteil

Créteil, , France

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CH de Dax

Dax, , France

Site Status

Cabinet privé

Dijon, , France

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Centre d'Oncologie du Parc

Dijon, , France

Site Status

Centre Georges François Leclerc

Dijon, , France

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CHU Hôpital du Bocage

Dijon, , France

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CHRU Grenoble

Grenoble, , France

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CH Région Saint-Omer

Helfaut, , France

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CH Lagny-sur-Marne

Lagny-sur-Marne, , France

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CH de Versailles

Le Chesnay, , France

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CH du Mans

Le Mans, , France

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Centre Oscar Lambret

Lille, , France

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Hôpital Calmette

Lille, , France

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CH de Longjumeau

Longjumeau, , France

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CH Lyon Sud - Pneumologie

Lyon, , France

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CH Saint Joseph Saint Luc

Lyon, , France

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Clinique Mutualiste Eugène André

Lyon, , France

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HIA Desgenettes

Lyon, , France

Site Status

Hôpital de la Croix Rousse

Lyon, , France

Site Status

Hôpital Ambroise Paré

Marseille, , France

Site Status

Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques

Marseille, , France

Site Status

Polyclinique du Parc

Maubeuge, , France

Site Status

CH de Macon

Mâcon, , France

Site Status

CHR Metz Thionville

Metz, , France

Site Status

CH de Mont-De-Marsan

Mont-de-Marsan, , France

Site Status

CH Montélimar

Montélimar, , France

Site Status

CH de Mulhouse

Mulhouse, , France

Site Status

CHU Nancy

Nancy, , France

Site Status

Hôpital Laënnec - CHU de Nantes

Nantes, , France

Site Status

CH Nevers

Nevers, , France

Site Status

Centre Antoine Lacassagne

Nice, , France

Site Status

CHR d'Orléans La Source

Orléans, , France

Site Status

GH Paris Saint-Joseph

Paris, , France

Site Status

Hôpital Bichat - Claude - Bernard

Paris, , France

Site Status

Hôpital Saint Antoine

Paris, , France

Site Status

Hôpital Tenon

Paris, , France

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CH de Rambouillet

Rambouillet, , France

Site Status

Institut Jean Godinot

Reims, , France

Site Status

CHU Charles Nicolle

Rouen, , France

Site Status

CH de Saint-Brieuc

Saint-Brieuc, , France

Site Status

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, , France

Site Status

CHU Strasbourg

Strasbourg, , France

Site Status

Hôpital Foch

Suresnes, , France

Site Status

Hôpitaux du Léman - Pneumologie et Maladies Infectieuses

Thonon-les-Bains, , France

Site Status

Hôpital Font-Pré - Pneumologie

Toulon, , France

Site Status

Clinique Pasteur

Toulouse, , France

Site Status

Clinique Saint Jean du Languedoc

Toulouse, , France

Site Status

Hôpital Larrey - Pneumologie

Toulouse, , France

Site Status

CHU Tours - Pneumologie

Tours, , France

Site Status

CH Valence

Valence, , France

Site Status

CHI de la Haute-Saône - Pneumologie

Vesoul, , France

Site Status

Clinique Mutualiste Les Portes du Sud

Vénissieux, , France

Site Status

CH de Villefranche - Pneumologie

Villefranche, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 25745045 (View on PubMed)

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.

Reference Type RESULT
PMID: 25657019 (View on PubMed)

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.

Reference Type RESULT
PMID: 25013125 (View on PubMed)

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.

Reference Type RESULT
PMID: 24034464 (View on PubMed)

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.

Reference Type RESULT
PMID: 32416585 (View on PubMed)

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.

Reference Type RESULT
PMID: 29074543 (View on PubMed)

Related Links

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http://www.ifct.fr/

Official website

Other Identifiers

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IFCT-1002 BioCAST

Identifier Type: -

Identifier Source: org_study_id

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