Lung cancer risk test trial: study design, participant baseline characteristics, bronchoscopy safety, and establishment of a biospecimen repository

BMC Pulmonary Medicine
E L CrawfordJ C Willey

Abstract

The Lung Cancer Risk Test (LCRT) trial is a prospective cohort study comparing lung cancer incidence among persons with a positive or negative value for the LCRT, a 15 gene test measured in normal bronchial epithelial cells (NBEC). The purpose of this article is to describe the study design, primary endpoint, and safety; baseline characteristics of enrolled individuals; and establishment of a bio-specimen repository. Eligible participants were aged 50-90 years, current or former smokers with 20 pack-years or more cigarette smoking history, free of lung cancer, and willing to undergo bronchoscopic brush biopsy for NBEC sample collection. NBEC, peripheral blood samples, baseline CT, and medical and demographic data were collected from each subject. Over a two-year span (2010-2012), 403 subjects were enrolled at 12 sites. At baseline 384 subjects remained in study and mean age and smoking history were 62.9 years and 50.4 pack-years respectively, with 34% current smokers. Obstructive lung disease (FEV1/FVC <0.7) was present in 157 (54%). No severe adverse events were associated with bronchoscopic brushing. An NBEC and matched peripheral blood bio-specimen repository was established. The demographic composition of the enrolled group...Continue Reading

Associated Clinical Trials

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Citations

Dec 23, 2016·Journal of Bronchology & Interventional Pulmonology·Christina R BellingerEdward F Haponik
Mar 7, 2018·BMC Pulmonary Medicine·Jiyoun YeoJames C Willey
Feb 22, 2018·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Ehab BillatosAvrum E Spira

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Methods Mentioned

BETA
biopsy
pregnancy test
PCR
genotyping

Clinical Trials Mentioned

NCT01130285
NCT01475500
NCT02504697

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