Mount Sinai's COFAR Clinical Research Unit and Clinical Trial (The "ADVANCE" Trial).

西奈山的 COFAR 临床研究单位和临床试验（“ADVANCE”试验）。

• 批准号: 10589847
• 负责人: SCOTT H SICHERER
• 金额: $ 23.5万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-03-05 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10589847
• 关键词: Adjuvant; Adult; Affect; Area; Biological; Biological Markers; Child; Clinical Research; Clinical Trials; Combined Modality Therapy; Diagnostic; Dose; Food Hypersensitivity; Goals; Immune response; Immunologics; Immunotherapy; Ingestion; Intervention Studies; Intervention Trial; Leadership; Mentors; Milk; Multicenter Studies; National Institute of Allergy and Infectious Disease; Observational Study; Oral; Participant; Prevention; Prevention strategy; Protocols documentation; Quality of life; Registries; Research; Research Personnel; Resources; Sampling; Site; base; cost; egg; epidemiology study; experience; food allergen; food challenge; improved; laboratory facility; next generation; novel; omalizumab; prevent; recruit; side effect; treatment strategy; treatment trial

MOUNT SINAI’S CoFAR CLINICAL RESEARCH UNIT AND CLINICAL TRIAL (THE “ADVANCE” TRIAL) Food allergy affects up to 8% of children and approximately 5% of adults, is a significant burden on quality of life, is costly, and can be fatal. Significant advances have been made in identifying potential treatment and prevention strategies. Oral (OIT), sublingual (SLIT), and epicutaneous (EPIT) immunotherapy, as well as combination therapy using OIT and omalizumab, and simply having children who are reactive to egg or milk ingest extensively heated forms if they can, have all shown promise to improve treatment. However, limitations of these approaches, including variable efficacy, side effects, costs, and lack of sustained unresponsiveness off treatment frame the need for better therapies. Exciting advances in prevention, specifically the efficacy of early introduction of peanut, have been recently noted. However, more needs to be done to identify the most effective prevention strategies. The objectives of the Consortium for Food Allergy Research (CoFAR) are to conduct ground-breaking trials and studies in treatment and prevention of food allergy, and to incorporate mechanistic studies. The long-term goals of CoFAR are to develop effective strategies to prevent and treat food allergies, and to elucidate underlying immunologic mechanisms. The major objective of the Mount Sinai CoFAR Clinical Research Unit (CRU) is to provide CoFAR with outstanding study opportunities and to propose a clinical trial to achieve the above stated goals. The Mount Sinai CRU team has been successfully and safely conducting food allergy research since 1997. It has contributed to every interventional study described above, and has an extensive portfolio of additional clinical studies. The CRU 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 clinical study. He also brings extensive experience from a myriad of areas of food allergy research, including additional treatment trials, registries, diagnostics, and performing quality of life and epidemiologic research and has been a mentor to numerous food allergy investigators. Co-Investigators Drs. Wang and Bunyavanich have served as successful PIs on clinical trials. Two early stage investigators are on the team and will benefit from their involvement to become the next generation of leaders in food allergy research. The Mount Sinai laboratory facilities have been the biomarker core for CoFAR and other multicenter studies and can easily manage biological samples at the direction of the Leadership Center (LC). The Mount Sinai CRU is located in Manhattan, with access to an extensive base of potential participants; it has safely conducted >20,000 oral food challenges and has a superb record of study recruitment and retention. To increase opportunities to contribute to CoFAR’s goals, a clinical trial is proposed using a novel experimental product that combines low dose food allergen with an adjuvant (enhancing a favorable immune response). In summary, the Mount Sinai CoFAR CRU brings extensive resources and experience to ensure that the goals of CoFAR, at the direction of the LC, Steering Committee and NIAID, are met.

西奈山的Cofar临床研究部门和临床试验（“预先”试验） 食物过敏会影响多达8％的儿童和大约5％的成年人，这是对质量的重大燃烧 生活是昂贵的，可能是致命的。在确定潜在治疗和 预防策略。口服（OIT），舌下（缝隙）和表皮（表位）免疫疗法以及 使用OIT和Omalizumab的联合疗法，仅生育于鸡蛋或牛奶的孩子 如果可以的话，摄入广泛加热的形式都显示出有望改善治疗的承诺。但是，局限性 在这些方法中，包括可变有效性，副作用，成本以及缺乏持续的无反应性 外治疗框架需要更好的疗法。令人兴奋的预防进步，特别是 最近已经指出了钢琴的早期引入。但是，需要做更多的事情才能确定最多的 有效的预防策略。食品过敏研究联盟（Cofar）的对象是 在食物过敏的治疗和预防方面进行开创性试验和研究，并纳入 机械研究。科法尔的长期目标是制定有效的策略来预防和治疗 食物过敏，并阐明潜在的免疫机制。西奈山的主要目标 Cofar临床研究部（CRU）将为Cofar提供出色的学习机会和提案 实现上述目标的临床试验。西奈山队已经成功安全地 自1997年以来进行食物过敏研究。 并拥有大量的其他临床研究组合。 Cru Pi，Scott Sicherer，医学博士，带来了广泛的 在过去的所有Cofar介入试验中都是现场PI的经验，并担任协议主席 Cofar观察性临床研究。他还从无数的食物中带来了丰富的经验 过敏研究，包括其他治疗试验，注册表，诊断和表现生活质量和 流行病学研究一直是众多食物过敏研究人员的心态。共同投资者Drs。 Wang和Bunyavanich在临床试验中已成为成功的PI。两个早期的调查人员正在 团队，将受益于他们的参与，成为食物过敏的下一代领导者 研究。西奈山实验室设施一直是科法尔和其他多中心的生物标志物核心 研究，可以轻松地在领导中心（LC）的方向上管理生物样品。坐骑 西奈克鲁（Sinai Cru）位于曼哈顿，拥有广泛的潜在参与者基地。它有安全的 进行了> 20,000个口腔食品挑战，并具有出色的研究招募和保留记录。到 增加了为Cofar目标做出贡献的机会，提出了一项临床试验，并使用新型的实验性试验 将低剂量食物过敏原与可调节的产品结合在一起（增强了有利的免疫反应）。在 总结，西奈山Cofar Cru带来了丰富的资源和经验，以确保目标的目标 在LC，指导委员会和NIAID的方向上，Cofar得到了满​​足。