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

BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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 is representative of the population for which the LCRT is intended. Specifically, based on baseline population characteristics we expect lung cancer incidence in this cohort to be representative of the population eligible for low-dose Computed Tomography (LDCT) lung cancer screening. Collection of NBEC by bronchial brush biopsy/bronchoscopy was safe and well-tolerated in this population. These findings support the feasibility of testing LCRT clinical utility in this prospective study. If validated, the LCRT has the potential to significantly narrow the population of individuals requiring annual low-dose helical CT screening for early detection of lung cancer and delay the onset of screening for individuals with results indicating low lung cancer risk. For these individuals, the small risk incurred by undergoing once in a lifetime bronchoscopic sample collection for LCRT may be offset by a reduction in their CT-related risks. The LCRT biospecimen repository will enable additional studies of genetic basis for COPD and/or lung cancer risk. TRIAL REGISTRATION: The LCRT Study, NCT 01130285, was registered with Clinicaltrials.gov on May 24, 2010.

Sleep characteristics in Goldenhar Syndrome.

OBJECTIVE: To examine the characteristics of sleep in patients with Goldenhar Syndrome. DESIGN: Retrospective review of all polysomnography studies conducted at the University of North Carolina Hospitals between 2003 and 2013 on patients carrying the diagnosis of Goldenhar's Syndrome. RESULTS: A preponderance of patients demonstrated severe obstructive sleep apnea and hypercapnia. CONCLUSIONS: Patients with Goldenhar Syndrome should be screened for sleep apnea and hypercapnia.

Categorical perception of a natural, multivariate signal: mating call recognition in túngara frogs.

Categorical perception is common in humans, but it is not known whether animals perceive continuous variation in their own multidimensional social signals categorically. There are two components to categorical perception: labeling and discrimination. In the first, continuously variable stimuli on each side of a category boundary are labeled. In the second, there is strong discrimination between stimuli from opposite sides of the boundary, whereas stimuli on the same side of the boundary are not discriminated. Here, we show that female túngara frogs respond categorically to complex mating calls that vary simultaneously along multiple dimensions and are within the natural range of signal variation. In response to a transect of synthetic stimuli that varied continuously and systematically in seven dimensions, female túngara frogs label mating calls as either conspecific or not conspecific. For pairs of stimuli that differed by the same magnitude, females discriminate those in different categories but not those in the same category. In addition, latency to respond was significantly shorter when stimuli were in the same versus different categories. Because responses to mating calls are critical in generating species recognition and sexual selection, this finding has implications for both animal perception and the influences of mate choice on the tempo and mode of evolution.