French Biological Observatory on Lung Cancer in Never Smokers

Completed

• Conditions: Lung Cancer

• Registration Number: NCT01465854
• Lead Sponsor: Intergroupe Francophone de Cancerologie Thoracique

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.

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 Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-02
• Study First Submitted QC: 2011-11-04
• Study First Posted: 2011-11-06
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 422

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of EGFR mutations in never smokers with newly diagnosed non-small-cell lung cancer (NSCLC)	November 2011 to January 2013

Trial Locations

Locations (82)

Centre Hospitalier du Pays d'Aix; 🇫🇷 Aix-en-Provence, France

CHD Castelluccio; 🇫🇷 Ajaccio, France

Clinique Claude Bernard; 🇫🇷 Albi, France

CHU d'Angers; 🇫🇷 Angers, France

CHI Annemasse-Bonneville; 🇫🇷 Annemasse, France

CH Annonay; 🇫🇷 Annonay, France

Hôpital Privé d'Antony; 🇫🇷 Antony, France

CHIC; 🇫🇷 Aulnay-Sous-Bois, France

CH de la Côte Basque; 🇫🇷 Bayonne, France

CHU Besançon; 🇫🇷 Besançon, France

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