Develop an appropriate real-world data comparator cohort to support the design, execution, and serve as an external control for interventional clinical trials in PSC.
Global, multi-center longitudinal observational cohort study. Collection of prospective clinical data to include liver-related clinical outcomes and safety events, hepatobiliary malignancies, relevant key biomarkers, imaging assessments, PSC-related clinical symptoms, patient-reported outcomes, and medication use in adult patients with PSC.
Study Type
OBSERVATIONAL
Enrollment
2,000
UC Davis
Sacramento, California, United States
RECRUITINGDevelop an appropriate real-world data (RWD) comparator cohort to support the design, execution, and serve as an external control for interventional clinical trials in PSC.
Collection of liver-related data including PSC symptoms, medical history, adverse events, and outcomes at enrollment and each quarterly and annual visit.
Time frame: Quarterly for five years from enrollment
Develop a large clinical and biomarker data set to identify individual and/or composite surrogate end-points likely to predict clinical benefit for use in the design of interventional studies in PSC.
Collection of biomarkers at enrollment and each annual visit.
Time frame: Quarterly for five years from enrollment
Develop a large clinical and biomarker data set to identify individual and/or composite surrogate end-points likely to predict clinical benefit for use in the design of interventional studies in PSC.
Collection of imaging at enrollment and each annual visit.
Time frame: Quarterly for five years from enrollment
Evaluate direct participant experiences with standardized tools to determine changes over time, the association with clinical events, biomarkers, and disease progression
Patient Reported Outcomes surveys will be collected from all participants at enrollment and each quarterly and annual visit.
Time frame: Quarterly for five years from enrollment
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California Pacific Medical Center
San Francisco, California, United States
RECRUITINGUniversity of California, San Francisco
San Francisco, California, United States
RECRUITINGYale University
New Haven, Connecticut, United States
RECRUITINGSchiff Center for Liver Diseases / University of Miami
Miami, Florida, United States
RECRUITINGIndiana University
Indianapolis, Indiana, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGUT Southwestern Medical Center
Dallas, Texas, United States
RECRUITING...and 8 more locations