This is a cooperative agreement application for a central data coordinating center (DCC) to develop a patient registry aimed at determining the natural history of interstitial cystitis (IC). the DCC will develop and implement a data and patient specimen collection system, assure quality control and provide appropriate detailed data reports to the Steering Committee and to the External Advisory Committee at regular intervals, and will be responsible for the logistics and planning for meetings of these committees. the DCC, located at the Pennsylvania State University Hershey Medical Center, will participate collaboratively with the Steering Committee in finalizing the study protocol and manual of operations. Based on these documents, the DCC will develop an appropriate set of data collection forms in close cooperation with the Steering Committee and the four designated Clinical Centers to ensure ease of use and high reliability and validity. Uniformly collected data on demographic, medical history, diagnostic procedure results, symptoms, treatment and outcome will be transmitted to the DCC at Hershey, where all stages of data management, including entry, verification, error correcting, accrual reporting and analysis will be conducted. Clinical samples of blood and urine will be sent to the Core Clinical Laboratory (CCL), also at Hershey, and bladder biopsy samples will be sent directly to the core Anatomical Pathology Laboratory (APL) at the University of Pennsylvania, also the site of one of the four Clinical Centers. Biopsy slides prepared at the APL under standardized procedures will be sent to each member of an expert panel of four anatomic pathologists for independent readings. Conflicts on biopsy findings will be resolved at an annual meeting of the expert panel. Results from both core laboratories, the CCL and the APL, including the consensus findings from the expert panel, will be sent on standardized data collection forms to the DCC to be incorporated into the registry database. The Core Laboratories will provide periodic training in specimen collection and transport procedures. the DCC will provide epidemiological study design and biostatistical analysis expertise to Steering Committee Investigators developing focused research questions. the DCC also will provide interim biostatistical analyses as required by the Committees and Clinical Centers, and will prepare a final set of specified analyses for targeted subgroups of patients. Although the specific research aims of the study are to be developed collaboratively with the Steering Committee, they will include i) descriptive analyses characterizing the age, gender, race and other demographic characteristics of IC patients stratified by diagnostic criteria subgroupings; ii) identification of associations between medical history, diagnostic procedure results, symptoms and IC classification status; iii) longitudinal profiles, adjusting for baseline characteristics and treatment regimens, characterizing the natural history of IC. This proposal indicates willingness to consider budgetary flexibility to accommodate scope of work actually developed by the Steering Committee.
