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Lung CancerBioCASTNCT01465854

French Biological Observatory on Lung Cancer in Never Smokers

An observational study of Lung Cancer, run by Intergroupe Francophone de Cancerologie Thoracique at 82 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
How many people
422 participants
Where
82 sitesFrance
Study dates
Nov 2011to Jan 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Never smokers with newly diagnosed lung cancer

Who may be able to join

  • 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

Who cannot join

  • smokers
  • chemotherapy already initiated at enrollment

Trial locations and contacts

82 sites in 1 country.

82 sites in 1 country

France82 sites

  • Centre Hospitalier du Pays d'Aix

    Aix-en-Provence

  • CHD Castelluccio

    Ajaccio

  • Clinique Claude Bernard

    Albi

  • CHU d'Angers

    Angers

  • CHI Annemasse-Bonneville

    Annemasse

  • CH Annonay

    Annonay

  • Hôpital Privé d'Antony

    Antony

  • CHIC

    Aulnay-sous-Bois

  • CH de la Côte Basque

    Bayonne

  • CHU Besançon

    Besançon

  • Hôpital Ambroise Paré - Pneumologie

    Boulogne

  • Hôpital Fleyriat

    Bourg-en-Bresse

  • CH Jacques-Cœur - Pneumologie

    Bourges

  • CH Pierre Oudot

    Bourgoin

  • HCL Hôpital Louis Pradel

    Bron

  • Centre François Baclesse

    Caen

  • CHU Côte de Nâcre

    Caen

  • CH Cahors

    Cahors

  • CH de Cannes

    Cannes

  • Centre Médical Nicolas de Pontoux

    Châlon-sur-Saône

  • CH de Châlons-en-Champagne

    Châlons-en-Champagne

  • CH Chambery

    Chambéry

  • CH de Chartres Hôpital Louis Pasteur

    Chartres

  • CH de Chauny

    Chauny

  • Hôpital de Cholet - Pneumologie

    Cholet

  • HIA Percy - Pneumologie

    Clamart

  • Hôpitral Gabriel Montpied - Pneumologie

    Clermont-Ferrand

  • Hôpital Pasteur

    Colmar

  • CH Compiègne - Pneumologie

    Compiègne

  • CHI Créteil

    Créteil

  • CH de Dax

    Dax

  • Cabinet privé

    Dijon

  • Centre d'Oncologie du Parc

    Dijon

  • Centre Georges François Leclerc

    Dijon

  • CHU Hôpital du Bocage

    Dijon

  • CHRU Grenoble

    Grenoble

  • CH Région Saint-Omer

    Helfaut

  • CH Lagny-sur-Marne

    Lagny-sur-Marne

  • CH de Versailles

    Le Chesnay

  • CH du Mans

    Le Mans

  • Centre Oscar Lambret

    Lille

  • Hôpital Calmette

    Lille

  • CH de Longjumeau

    Longjumeau

  • CH Lyon Sud - Pneumologie

    Lyon

  • CH Saint Joseph Saint Luc

    Lyon

  • Clinique Mutualiste Eugène André

    Lyon

  • HIA Desgenettes

    Lyon

  • Hôpital de la Croix Rousse

    Lyon

  • CH de Macon

    Mâcon

  • Hôpital Ambroise Paré

    Marseille

  • Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques

    Marseille

  • Polyclinique du Parc

    Maubeuge

  • CHR Metz Thionville

    Metz

  • CH de Mont-De-Marsan

    Mont-de-Marsan

  • CH Montélimar

    Montélimar

  • CH de Mulhouse

    Mulhouse

  • CHU Nancy

    Nancy

  • Hôpital Laënnec - CHU de Nantes

    Nantes

  • CH Nevers

    Nevers

  • Centre Antoine Lacassagne

    Nice

  • CHR d'Orléans La Source

    Orléans

  • GH Paris Saint-Joseph

    Paris

  • Hôpital Bichat - Claude - Bernard

    Paris

  • Hôpital Saint Antoine

    Paris

  • Hôpital Tenon

    Paris

  • CH de Rambouillet

    Rambouillet

  • Institut Jean Godinot

    Reims

  • CHU Charles Nicolle

    Rouen

  • CH de Saint-Brieuc

    Saint-Brieuc

  • Institut de Cancérologie de la Loire

    Saint-Priest-en-Jarez

  • CHU Strasbourg

    Strasbourg

  • Hôpital Foch

    Suresnes

  • Hôpitaux du Léman - Pneumologie et Maladies Infectieuses

    Thonon-les-Bains

  • Hôpital Font-Pré - Pneumologie

    Toulon

  • Clinique Pasteur

    Toulouse

  • Clinique Saint Jean du Languedoc

    Toulouse

  • Hôpital Larrey - Pneumologie

    Toulouse

  • CHU Tours - Pneumologie

    Tours

  • CH Valence

    Valence

  • Clinique Mutualiste Les Portes du Sud

    Vénissieux

  • CHI de la Haute-Saône - Pneumologie

    Vesoul

  • CH de Villefranche - Pneumologie

    Villefranche

Other trials in France

About this study

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.

Read the 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.

Conditions
Lung Cancer
Keywords
lung cancer, smoking, molecular epidemiology, genetic polymorphism, risk factors, never smokers, histologically/cytologically confirmed, IFCT
Medical subject headings
Lung Neoplasms, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01465854
Study groupRoleWhat they receive
LCINSNever smokers with newly diagnosed lung cancer

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: November 2011 to January 2013

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
422 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01465854
Sponsor's protocol ID
IFCT-1002 BioCAST
Acronym
BioCAST
Status last verified
May 2023
First submitted
2 Nov 2011
Last updated
24 May 2023
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25745045

  • 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.

    PubMed 25657019

  • 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.

    PubMed 25013125

  • 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.

    PubMed 24034464

  • 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.

    PubMed 32416585

  • 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.

    PubMed 29074543

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer, run by Intergroupe Francophone de Cancerologie Thoracique at 82 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of EGFR mutations in never smokers with newly diagnosed non-small-cell lung cancer (NSCLC) (time frame: November 2011 to January 2013). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01465854, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.

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