French Biological Observatory on Lung Cancer in Never Smokers (BioCAST)
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|ClinicalTrials.gov Identifier: NCT01465854|
Recruitment Status : Completed
First Posted : November 7, 2011
Last Update Posted : October 2, 2017
|Condition or disease|
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 Type :||Observational|
|Actual Enrollment :||422 participants|
|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|
Never smokers with newly diagnosed lung cancer
- 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
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01465854
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|Principal Investigator:||Sebastien COURAUD, MD||Hospices Civils de Lyon, CH Lyon Sud, FRANCE|