NCT01465854

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
422

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

82 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

November 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 7, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

November 2, 2011

Last Update Submit

May 22, 2023

Conditions

Keywords

lung cancersmokingmolecular epidemiologygenetic polymorphismrisk factorsnever smokershistologically/cytologically confirmedIFCT

Outcome Measures

Primary Outcomes (1)

  • Prevalence of EGFR mutations in never smokers with newly diagnosed non-small-cell lung cancer (NSCLC)

    November 2011 to January 2013

Study Arms (1)

LCINS

Never smokers with newly diagnosed lung cancer

Eligibility Criteria

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

Never smokers with newly diagnosed lung cancer

You may qualify if:

  • 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

You may not qualify if:

  • smokers
  • chemotherapy already initiated at enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (82)

Centre Hospitalier du Pays d'Aix

Aix-en-Provence, France

Location

CHD Castelluccio

Ajaccio, France

Location

Clinique Claude Bernard

Albi, France

Location

CHU d'Angers

Angers, France

Location

CHI Annemasse-Bonneville

Annemasse, France

Location

CH Annonay

Annonay, France

Location

Hôpital Privé d'Antony

Antony, France

Location

CHIC

Aulnay-sous-Bois, France

Location

CH de la Côte Basque

Bayonne, France

Location

CHU Besançon

Besançon, France

Location

Hôpital Ambroise Paré - Pneumologie

Boulogne, France

Location

Hôpital Fleyriat

Bourg-en-Bresse, France

Location

CH Jacques-Cœur - Pneumologie

Bourges, France

Location

CH Pierre Oudot

Bourgoin, France

Location

HCL Hôpital Louis Pradel

Bron, France

Location

Centre François Baclesse

Caen, France

Location

CHU Côte de Nâcre

Caen, France

Location

CH Cahors

Cahors, France

Location

CH de Cannes

Cannes, France

Location

CH Chambery

Chambéry, France

Location

CH de Chartres Hôpital Louis Pasteur

Chartres, France

Location

CH de Chauny

Chauny, France

Location

Centre Médical Nicolas de Pontoux

Châlon-sur-Saône, France

Location

CH de Châlons-en-Champagne

Châlons-en-Champagne, France

Location

Hôpital de Cholet - Pneumologie

Cholet, France

Location

HIA Percy - Pneumologie

Clamart, France

Location

Hôpitral Gabriel Montpied - Pneumologie

Clermont-Ferrand, France

Location

Hôpital Pasteur

Colmar, France

Location

CH Compiègne - Pneumologie

Compiègne, France

Location

CHI Créteil

Créteil, France

Location

CH de Dax

Dax, France

Location

Cabinet privé

Dijon, France

Location

Centre d'Oncologie du Parc

Dijon, France

Location

Centre Georges François Leclerc

Dijon, France

Location

CHU Hôpital du Bocage

Dijon, France

Location

CHRU Grenoble

Grenoble, France

Location

CH Région Saint-Omer

Helfaut, France

Location

CH Lagny-sur-Marne

Lagny-sur-Marne, France

Location

CH de Versailles

Le Chesnay, France

Location

CH du Mans

Le Mans, France

Location

Centre Oscar Lambret

Lille, France

Location

Hôpital Calmette

Lille, France

Location

CH de Longjumeau

Longjumeau, France

Location

CH Lyon Sud - Pneumologie

Lyon, France

Location

CH Saint Joseph Saint Luc

Lyon, France

Location

Clinique Mutualiste Eugène André

Lyon, France

Location

HIA Desgenettes

Lyon, France

Location

Hôpital de la Croix Rousse

Lyon, France

Location

Hôpital Ambroise Paré

Marseille, France

Location

Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques

Marseille, France

Location

Polyclinique du Parc

Maubeuge, France

Location

CH de Macon

Mâcon, France

Location

CHR Metz Thionville

Metz, France

Location

CH de Mont-De-Marsan

Mont-de-Marsan, France

Location

CH Montélimar

Montélimar, France

Location

CH de Mulhouse

Mulhouse, France

Location

CHU Nancy

Nancy, France

Location

Hôpital Laënnec - CHU de Nantes

Nantes, France

Location

CH Nevers

Nevers, France

Location

Centre Antoine Lacassagne

Nice, France

Location

CHR d'Orléans La Source

Orléans, France

Location

GH Paris Saint-Joseph

Paris, France

Location

Hôpital Bichat - Claude - Bernard

Paris, France

Location

Hôpital Saint Antoine

Paris, France

Location

Hôpital Tenon

Paris, France

Location

CH de Rambouillet

Rambouillet, France

Location

Institut Jean Godinot

Reims, France

Location

CHU Charles Nicolle

Rouen, France

Location

CH de Saint-Brieuc

Saint-Brieuc, France

Location

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, France

Location

CHU Strasbourg

Strasbourg, France

Location

Hôpital Foch

Suresnes, France

Location

Hôpitaux du Léman - Pneumologie et Maladies Infectieuses

Thonon-les-Bains, France

Location

Hôpital Font-Pré - Pneumologie

Toulon, France

Location

Clinique Pasteur

Toulouse, France

Location

Clinique Saint Jean du Languedoc

Toulouse, France

Location

Hôpital Larrey - Pneumologie

Toulouse, France

Location

CHU Tours - Pneumologie

Tours, France

Location

CH Valence

Valence, France

Location

CHI de la Haute-Saône - Pneumologie

Vesoul, France

Location

Clinique Mutualiste Les Portes du Sud

Vénissieux, France

Location

CH de Villefranche - Pneumologie

Villefranche, France

Location

Related 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 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, plama, white cells

MeSH Terms

Conditions

Lung NeoplasmsSmoking

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBehavior

Study Officials

  • Sebastien COURAUD, MD

    Hospices Civils de Lyon, CH Lyon Sud, FRANCE

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 2, 2011

First Posted

November 7, 2011

Study Start

November 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

May 24, 2023

Record last verified: 2023-05

Locations