Data Coordinating Center for the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Continuation

Johns Hopkins University, Baltimore MD

Investigators

Linked publications & trials

Abstract

Data Coordinating Center for the NASH Clinical Research Network (NASH CRN) ABSTRACT Nonalcoholic fatty liver disease (NAFLD) has become the most common form of chronic liver disease in the developed world and affects both adults and children. NAFLD, and especially nonalcoholic steatohepatitis (NASH), may lead to liver cancer and cirrhosis requiring liver transplant, as well as liver-, cardiovascular-, and cancer-related morbidity and mortality, resulting in increased health burdens and associated costs. The Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) has been funded by the National Institutes of Health (NIH) since 2002 and has provided important information regarding the natural history and treatment of NAFLD/NASH in adults and children, and has set the stage for translational research focused on the pathogenesis, diagnosis, treatment, and clinical management of these patients. This application is in response to the Limited Competition for the Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Data Coordinating Center (DCC) (RFA-DK-23-516). Our aims in response to the RFA are: 1) Coordinate completion of enrollment, execution, analysis, and publication of the Vitamin E Dosing Study (VEDS) clinical trial; 2) Coordinate completion of enrollment, execution, analysis, and publication of the NAFLD Database 3 study, including the completion of the FibroScan Spleen Stiffness Measurement and SmartExam Software (SSMS) Substudy; and 3) Facilitate the use of biospecimen, histological, and clinical data to develop and validate non-invasive biomarkers for the diagnosis and staging of NASH; genomic and transcriptomic data to advance understanding of genetic predictors; and proteomic, metabolic, and lipidomic data to advance understanding of pathogenesis and inform diagnosis, treatment, and clinical management. The DCC will provide the NASH CRN with leadership, biostatistical analysis, study closeout, data management, multicenter coordination, quality control, safety oversight, project support, and communication. The DCC is eager to continue its collaboration with the Clinical Centers, NIDDK program staff, and private sector partners to complete these important research objectives. The global hepatology community has established a new nomenclature: NAFLD is now metabolic dysfunction-associated steatotic liver disease (MASLD), which includes patients who have hepatic steatosis and at least one of five cardiometabolic risk factors. MetALD describes those with MASLD who consume greater amounts of alcohol per week, and metabolic dysfunction-associated steatohepatitis (MASH) is the replacement term for NASH. Steatotic liver disease (SLD) is an overall term covering all etiologies of steatosis. The NASH CRN is poised to usher in this change and continue to advance the mission of the NIH to improve the health of the public with its major impact on the field. The DCC will ensure that the NASH CRN resources are positioned to be accessible to all researchers after the close of the network.