The Human Subjects Core will provide a core resource for the recruitment of human participants for clinical studies that support the aims of the projects. Recruiting human subjects for mechanism-oriented clinical research protocols requires well-developed systems to ensure successful subject recruitment and the collection of high quality biospecimens from well-characterized human subjects. The Core will serve all projects, and it will provide strong resources for the safe conduct of human-based research. The clinical studies conducted by the core involve complicated protocols that include virtual navigational bronchoscopy. The infrastructure required to support this kind of human research is complex and challenging and the core provides experienced and highly trained personnel to meet this challenge. Therefore, the first aim of the core is to provide a human subjects core for PPG investigators with strong personnel resources and effective participant recruitment systems to ensure the safe conduct of the protocols, compliance with regulatory requirements, and timely recruitment.
The second aim of the core is to enroll human participants in two clinical studies to support the three PPG projects: (i) ?Study Of Focal Airway disease in Asthma using Image Guided Bronchoscopy? - ?SOFA study?; this study is notable for its use of virtual navigational bronchoscopy to allow directed collection of airway biospecimens from mucus plugged airways and control airways (patent airways); (ii) ?Tissue Immune interaction in nasal Polyposis - ?TIP study?. The TIP study is notable for its collection of nasal polyp tissue and sinus mucus samples. Both studies will provide high quality biospecimens from either lower airway (SOFA study) or upper airway (TIP study) type 2 niches.
Mechanism oriented clinical research is enabled by collection of high quality biospecimens from well characterized patients, and this human subjects core will collect airway biospecimens under rigorous conditions from two patient groups who have ?type 2 niches in their airway. One group will be patients with nasal polyps (upper airway type 2 niches) and the other will be asthmatic patients with mucus plugs in their lower airways (lower airway type 2 niches). The collection of these biospecimens will enable research into the biological mechanisms that underlie persistent type 2 inflammation in asthma.
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