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.

Genetic forms of HIV Type 1 in the former Soviet Union dominate the epidemic in Azerbaijan.

A total of 125 strains collected in Azerbaijan between 1999 and 2002 from HIV seropositives were genetically classified. Of 84 strains classified using HMA, 91.6% were subtype A, 1.2% subtype B, and 7.1% untypeable. Of 41 strains analyzed using partial pol gene sequences, 90.2% were subtype A, 7.3% subtype B, and 2.4% CRF03_AB. Most sequenced A strains clustered with those circulating in countries of the former Soviet Union (FSU). Two of three sequenced B strains were from individuals who traveled to FSU clustering tightly with B strains from Nikolayev, Ukraine. CRF03_AB, characteristic of the 1996 epidemic in Kaliningrad, Russia, was sequenced from an individual who lived in Russia from 1995 until 2001. The HIV epidemic in Azerbaijan is concentrated in IDU and is closely connected to other such epidemics to the east based on genetics. Of the 41 sequenced strains, 95% were close genetic relatives of HIV strains in IDU networks in the FSU.

Human orf (ecthyma contagious) a report of two cases from Saudi Arabia.

Two cases of orf occuring in one family are reported. The patients developed characteristic skin lesions one week after sustaining cuts while slaughtering a sheep. The diagnosis of orf was confirmed by electron microscopy which revealed numerous large oval virus particle characteristics of parapox virus. This we believe is the first report of orf in Saudi Arabia.