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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:
NCT01465854
First received: November 2, 2011
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

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
Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: French Biological Observatory on Lung Cancer in Never Smokers

Resource links provided by NLM:


Further study details as provided by Intergroupe Francophone de Cancerologie Thoracique:

Primary Outcome Measures:
  • Prevalence of EGFR mutations in never smokers with newly diagnosed non-small-cell lung cancer (NSCLC) [ Time Frame: November 2011 to January 2013 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood, serum, plama, white cells


Enrollment: 422
Study Start Date: November 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
LCINS
Never smokers with newly diagnosed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465854

  Show 82 Study Locations
Sponsors and Collaborators
Intergroupe Francophone de Cancerologie Thoracique
Investigators
Principal Investigator: Sebastien COURAUD, MD Hospices Civils de Lyon, CH Lyon Sud, FRANCE
  More Information

Additional Information:
No publications provided

Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier: NCT01465854     History of Changes
Other Study ID Numbers: IFCT-1002 BioCAST
Study First Received: November 2, 2011
Last Updated: July 12, 2013
Health Authority: France: Ministère de l'Enseignement supérieur et de la Recherche
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

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:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014