Human Subjects and Statistics Core

Washington University, Saint Louis MO

Investigators

Linked publications & trials

Abstract

The overall goal of the Human Subjects and Statistics Core is to provide biologic samples and clinical[unreadable] information from well-defined human subjects to enable each of the scientific projects in the AADCRC to[unreadable] translate their findings to the bedside. The Asthma and Airways Translational Research Unit (AATRU) at[unreadable] Washington University School of Medicine has a long track record of successfully recruiting human subjects[unreadable] and carefully characterizing these subjects with physiologic, imaging and biologic methods. This Core will[unreadable] eliminate duplication of effort regarding subject recruitment, collection of clinical subject data, the[unreadable] performance of specialized procedures such as bronchoscopy with bronchoalveolar lavage, brushings and[unreadable] endobronchial biopsies and initial processing of blood, BAL, and biopsy specimens. Biopsies will then be[unreadable] submitted to the Morphology and Microscopy Core for preparation. The Core will conduct all clinical studies[unreadable] and provide for subject management throughout all procedures. Accordingly, the Human Subjects and[unreadable] Statistics core will: I) Recruit and characterize mild to severe stable asthmatic subjects with a control group[unreadable] of normal and chronic bronchitis subjects for participation in the AADCRC, II) Characterize prospectively a[unreadable] case-controlled study of children with metapneumovirus (hMPV) bronchiolitis, using biologic, immunologic,[unreadable] and physiologic measures, to evaluate the determinants of recurrent persistent wheezing and subsequently,[unreadable] an asthmatic phenotype, and III) Maintain the AATRU Database and provide statistical analysis of data from[unreadable] each of the component projects and assist each project to correlate these findings with clinical data. The first[unreadable] protocol (Aim I) will ensure that there are adequate biologic samples on well-characterized subjects with[unreadable] asthma and appropriate controls. The second protocol (Aim II) will evaluate the effects of hMPV infection on[unreadable] airway biology during a native respiratory tract infection leading to a wheezing respiratory illness. This cohort[unreadable] of children will be followed over a three-yr. period to determine which ones develop persistent wheezing, a[unreadable] phenotype associated with asthma, following a serious hMPV infection. The molecular events in the airway[unreadable] triggered by viruses have not been well elucidated in vivo. This protocol will allow the individual projects l-lll[unreadable] to investigate molecular mechanisms and/or markers triggered in the setting of a native hMPV respiratory[unreadable] tract infection associated with wheezing. Furthermore, these molecular markers will be followed in this cohort[unreadable] over the subsequent three yrs. to assess for their persistence in those children that develop persistent[unreadable] wheezing. Lastly, the Human Subjects and Statistics Core will allow for the most consistent project-wide[unreadable] database with comparison and correlation of data, including the correlation of pathologic markers with clinical[unreadable] parameters (Aim III). This will enable critical findings from the AADCRC into the innate and adaptive immune[unreadable] signals that are central to the pathogenesis of asthma to be translated to the patient.