French Biological Observatory on Lung Cancer in Never Smokers (BioCAST)
| Tracking Information | |||||
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| First Received Date ICMJE | November 2, 2011 | ||||
| Last Updated Date | October 16, 2012 | ||||
| Start Date ICMJE | November 2011 | ||||
| Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01465854 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | French Biological Observatory on Lung Cancer in Never Smokers | ||||
| Official Title ICMJE | French Biological Observatory on Lung Cancer in Never Smokers | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: whole blood, serum, plama, white cells |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Never smokers with newly diagnosed lung cancer |
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| Condition ICMJE | Lung Cancer | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | LCINS
Never smokers with newly diagnosed lung cancer |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 1000 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01465854 | ||||
| Other Study ID Numbers ICMJE | IFCT-1002 BioCAST | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Intergroupe Francophone de Cancerologie Thoracique | ||||
| Study Sponsor ICMJE | Intergroupe Francophone de Cancerologie Thoracique | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Intergroupe Francophone de Cancerologie Thoracique | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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