Multiple Allergic Diseases REPository (MADREP)

National Institute Of Allergy And Infectious Diseases

Investigators

Abstract

In FY25, significant progress was made in the biorepository study, with the successful initiation of the protocol and the opening of the clinic. Efforts to develop the protocol and infrastructure focused on collecting data and samples to define clinical outcomes related to atopic or sinus diseases, study or create disease outcome metrics (e.g., PRO/CROs), and understand mechanisms of allergic diseases, including defining predictive biomarkers, phenotypes, or endotypes from body fluids or tissues collected during clinical care. Coordination of governance and storage of biological samples (blood, tissue, urine) and data coded using common data elements was pursued across several teams, incorporating REDCAP, LabKey, laboratory personnel, data analytics, and clinical teams. The protocol successfully passed scientific and regulatory review and is now operational, serving as a valuable resource to enhance the scope, depth, and reliability of epidemiologic studies and drive advancements in understanding and phenotyping diseases. Since February 2025, rapid enrollment and scaling have been achieved, with 33 participants enrolled and 77 patient visits conducted. The clinic has facilitated 2 drug challenges, 4 food challenges, 1 endoscopy, and 2 polyp biopsies, with associated samples collected in a short time period, demonstrating the swift implementation and expansion of study activities. As the only academic civilian allergy-immunology clinic in the immediate DMV area, it has served as a valuable continuity clinic site for the NIAID A&I program.