North American PSC Database
This is a longitudinal, observational study of patients with PSC to address knowledge gaps in the clinical presentation, natural history, epidemiology, progression, and outcomes of PSC. In addition, the study will address prognostic models and biomarker development. There will be an option to participate in specimen repository at each site for translational studies of genomics and novel biomarkers discovery.
Patient management follows standard of care. No specific interventions, assessments, or testing are required by enrollment in the study. Participants consent to the abstraction of up to 10 years of retrospective, medical records including clinic notes, laboratory data, prior imaging reports, diagnostic procedures including endoscopic procedures, surgeries, and liver biopsy reports. Patients that are deceased or no longer followed at a site may be enrolled and have retrospective data collected and entered into the database with the approval of the appropriate IRB.
Patient management follows standard of care. No specific interventions, assessments, or testing are required by enrollment in the study. Participants consent to the abstraction of up to 10 years of retrospective, medical records including clinic notes, laboratory data, prior imaging reports, diagnostic procedures including endoscopic procedures, surgeries, and liver biopsy reports. Patients that are deceased or no longer followed at a site may be enrolled and have retrospective data collected and entered into the database with the approval of the appropriate IRB.
The North American PSC Database is one of many coordinated efforts to systematically collect data from patients with PSC in order to develop prognostic markers that can be used to predict clinical outcomes and eventually act as surrogate markers for clinical trials, a major barrier to the development of treatments for PSC. These efforts were initiated through the International PSC Study Group and produced a common database including over 7,000 patients. However, the dataset was limited and spanned several decades. Currently, several regional efforts are underway to collect more timely and detailed data which is needed to achieve the goals stated above. In order to maximize the utility of these efforts, a set of common database elements have been developed with the goal to combine the data into a common database.
