Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

French Biological Observatory on Lung Cancer in Never Smokers (BioCAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01465854
Recruitment Status : Completed
First Posted : November 6, 2011
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Lung Cancer

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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 422 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: French Biological Observatory on Lung Cancer in Never Smokers
Study Start Date : November 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
LCINS
Never smokers with newly diagnosed lung cancer


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Prevalence of EGFR mutations in never smokers with newly diagnosed non-small-cell lung cancer (NSCLC) [ Time Frame: November 2011 to January 2013 ]

Biospecimen Retention:   Samples With DNA
whole blood, serum, plama, white cells

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Never smokers with newly diagnosed lung cancer
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01465854


Locations
Show Show 82 study locations
Sponsors and Collaborators
Intergroupe Francophone de Cancerologie Thoracique
Investigators
Layout table for investigator information
Principal Investigator: Sebastien COURAUD, MD Hospices Civils de Lyon, CH Lyon Sud, FRANCE
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier: NCT01465854    
Other Study ID Numbers: IFCT-1002 BioCAST
First Posted: November 6, 2011    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017
Keywords provided by Intergroupe Francophone de Cancerologie Thoracique:
lung cancer
smoking
molecular epidemiology
genetic polymorphism
 risk factors
never smokers
histologically/cytologically confirmed
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases