Thursday, May 29, 2025
5/29/2025
Mount Sinai's CoFAR Clinical Research Center - Project Summary/Abstract MOUNT SINAI’S CoFAR CLINICAL RESEARCH CENTER Food allergy is estimated to affect approximately 8% of children and 10% of adults; in the US this translates to 32 million people. Food allergy is potentially life-threatening, significantly impacts quality of life and nutrition, and carries a high economic burden. Although significant advances have been made for prevention and therapy, prevalence rates remain high and therapeutic options are few. The long-term goals of CoFAR are to develop effective strategies to prevent and treat food allergies, and to elucidate underlying mechanisms. As the leadership center (LC) for CoFAR from 2005 to 2015, and as a CoFAR Clinical Research Center (CRC) for 17 years, we are the only CRC to have contributed to every CoFAR study, trial, and supplemental projects, with leadership roles in 9 projects, including the current SUNBEAM birth cohort study. The objectives of CoFAR CRCs is to conduct network-wide studies and trials and center-specific projects to advance knowledge, management and treatment across a range of food-allergic diseases, and to elucidate underlying mechanisms. The Mount Sinai CRC team has been successfully and safely conducting food allergy research since 1997. The CRC PI, Scott Sicherer, MD, brings broad experience having been site PI for all of the past CoFAR interventional trials, as well as being Protocol Chair of the CoFAR observational study and Co-Chair of SUNBEAM. Co-Investigators Drs. Wang and Bunyavanich (who serves as chair for the SUNBEAM biosampling program) have served as successful PIs on clinical trials. Early stage investigators on the team will benefit from their involvement to become the next generation of leaders in food allergy research. Our CRC laboratories have been the central biomarker facility for CoFAR and easily manage biological samples at the direction of the LC. The CRC is located in Manhattan, with access to an extensive base of potential participants; it has safely conducted >30,000 oral food challenges and has a superb record of study recruitment and retention. To increase opportunities to contribute to CoFAR’s goals, a Network-wide clinical trial is proposed to improve safety and allow dietary incorporation of common allergens; preliminary data suggest that potentially half of people living with IgE- mediated food allergy may benefit. Two site-specific studies will inform improving diversity, equity and inclusion in food allergy research, and inform pathogenesis and course of food allergy through a novel, non-invasive approach. In summary, the Mount Sinai CoFAR CRC brings extensive resources and experience to ensure that the goals of CoFAR, at the direction of the LC, Steering Committee and NIAID, are met.
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