We propose to develop and maintain a Data Coordinating Center (DCC) that will provide support for a network of clinical sites studying chronic pediatric liver disease. Specifically we will continue, expand, and merge the efforts of investigators from the Biliary Atresia Research Consortium (BARC) and the Cholestatic Liver Disease Consortium (CLiC) to form the Childhood Liver Disease Research Education Network (ChiLDREN).
The specific aims of the ChiLDREN DCC are to: 1. Integrate the data from all of the BARC and CLiC studies. 2. Continue to coordinate and refine the ongoing studies in these networks, providing assistance as necessary and monitoring sites for data quality. 3. Provide expertise in the design, conduct, and analysis of studies to be performed by the network. 4. Develop plans for data analysis, perform the analysis, and collaborate in the preparation of the presentations and publications that will arise from these studies. 5. Maintain the database for specimen tracking to coordinate with the NIDDK repositories. 6. Develop effective administrative systems to provide timely consultation, review, and assistance with implementation for ancillary studies approved by the ChiLDREN Steering Committee. 7. Coordinate the efforts of the ChiLDREN Steering Committee and all ChiLDREN committees and working groups by providing leadership and logistic support. 8. Develop and modify the Data Safety and Monitoring Plan for ChiLDREN, and facilitate the work of the Data Safety Monitoring Board, by monitoring and reporting adverse events as well as providing regular progress reports. 9. Develop and maintain an effective ChiLDREN website that serves as a resource to patients and their families, as well as ChiLDREN investigators and coordinators. Relevance: Chronic pediatric liver disease is a devastating condition that has profound impact on children, their families, and our society. Biliary atresia, along with the other cholestatic liver diseases studied by the Network, account for over half of liver transplants performed in children in the United States. A better understanding of the diseases studied by this Network will help provide better care of patients with chronic liver disease.

Agency
National Institute of Health (NIH)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01DK062456-12S2
Application #
8827462
Study Section
Special Emphasis Panel (ZDK1)
Program Officer
Sherker, Averell H
Project Start
Project End
Budget Start
Budget End
Support Year
12
Fiscal Year
2014
Total Cost
Indirect Cost
Name
University of Michigan Ann Arbor
Department
Surgery
Type
Schools of Medicine
DUNS #
City
Ann Arbor
State
MI
Country
United States
Zip Code
48109
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Bessho, Kazuhiko; Mourya, Reena; Shivakumar, Pranavkumar et al. (2014) Gene expression signature for biliary atresia and a role for interleukin-8 in pathogenesis of experimental disease. Hepatology 60:211-23
Sambrotta, Melissa; Strautnieks, Sandra; Papouli, Efterpi et al. (2014) Mutations in TJP2 cause progressive cholestatic liver disease. Nat Genet 46:326-8
Bezerra, Jorge A; Spino, Cathie; Magee, John C et al. (2014) Use of corticosteroids after hepatoportoenterostomy for bile drainage in infants with biliary atresia: the START randomized clinical trial. JAMA 311:1750-9
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Superina, Riccardo; Magee, John C; Brandt, Mary L et al. (2011) The anatomic pattern of biliary atresia identified at time of Kasai hepatoportoenterostomy and early postoperative clearance of jaundice are significant predictors of transplant-free survival. Ann Surg 254:577-85
Russo, Pierre; Magee, John C; Boitnott, John et al. (2011) Design and validation of the biliary atresia research consortium histologic assessment system for cholestasis in infancy. Clin Gastroenterol Hepatol 9:357-362.e2
Wang, Hongtao; Malone, James P; Gilmore, Petra Erdmann et al. (2010) Serum markers may distinguish biliary atresia from other forms of neonatal cholestasis. J Pediatr Gastroenterol Nutr 50:411-6
Weinberg, Marc S; Bhatt, Aadra P; Girotti, Milena et al. (2009) Repeated ferret odor exposure induces different temporal patterns of same-stressor habituation and novel-stressor sensitization in both hypothalamic-pituitary-adrenal axis activity and forebrain c-fos expression in the rat. Endocrinology 150:749-61

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