| SICCA-International Sjögren's Syndrome Registry: Design, Preliminary Findings, Future Directions | ||
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T.E. DANIELS1, J.S. GREENSPAN1, D. COX1, L.A. CRISWELL1, Y. DESOUZA1, D. YI2, D. GREENSPAN1, R. JORDAN1, H. LANFRANCHI3, K. SACK1, M. SCHIODT4, C. SHIBOSKI1, S. SHIBOSKI1, S. SUGAI5, H. UMEHARA5, J. WHITCHER1, and A.J. WU1, 1University of California, San Francisco, USA, 2Peking Union Medical College Hospital, Beijing, China, 3University of Buenos Aires, Argentina, 4Copenhagen Country University Hospital, Glostrup, Denmark, 5Kanazawa Medical University, Japan Objectives: Of the major autoimmune connective tissue diseases, Sjögren's syndrome (SS) is perhaps the least well understood. Increasing numbers of clinical-laboratory studies followed a key 1965 paper, but since then 9 sets of SS diagnostic criteria have been applied. Both primary and secondary forms of SS occur, but the phenotype of primary SS (pSS) is still not well defined. This 5-year NIH registry began in 2003 with goals of 1) designing and implementing an international SS registry, 2) developing standardized classification criteria, 3) collecting, processing and storing clinical data and biospecimens, and 4) providing these resources to researchers for future studies of SS. Methods: This multi-site, observational longitudinal study is named Sjögren's International Collaborative Clinical Alliance (SICCA). We developed protocol-directed examinations and procedures to record 698 variables and collect and freeze nine types of biospecimens from participants suspected of having SS, and DNA from family and population controls, at five international sites. Data is recorded on forms transmitted by DataFax software and frozen specimens are shipped quarterly to a coordinating center and repository in San Francisco. Defined participants are recalled after two years to repeat all observations. Data will then be analyzed to define the pSS phenotype and develop new diagnostic criteria, in collaboration with the American College of Rheumatology. Results: By January 2007, 1117 participants had been screened and 711 baseline evaluations completed. Initial cohort-wide analyses identify: symptoms of dry mouth and dry eyes in 80%; unstimulated whole salivary flow rates <0.1 ml/m in 53%; ocular staining with scores ≥4 in 52%; labial salivary gland biopsies with focus scores >1 in 43%; and serum anti-SS-A/-B in 39%. Conclusion: Substantial amounts of uniform SICCA clinical data and biospecimens will better define the pSS phenotype, develop new classification criteria, and create banks of data and biospecimens to support future research. NO1-DE-32636 | ||
| Seq #0 - Late Breaking News - Session I 9:00 AM-10:30 AM, Thursday, March 22, 2007 Ernest N. Morial Convention Center 287 | ||
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