Global Prospective, Observational Cohort of Adult Patients With Primary Sclerosing Cholangitis (WIND-PSC Study)
Part of paid clinical trials in Sacramento, California.
- Sponsor
- PSC Partners Seeking a Cure
- Study ID
- NCT06297993
- Status
- Recruiting
Conditions
- PSC
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- Start date
- May 6, 2024
- Status verified
- Feb 2026
- Primary completion
- Jan 31, 2029
- Completion
- Jan 31, 2031
Study Design
- Enrollment
- 2,000 participants (estimated)
Arms
- Arm: Adult patients with a confirmed diagnosis of large duct PSC.1. Adult patients between 18 and 75 years of age (inclusive) who can comprehend instructions, follow the study procedures and are willing to sign an Informed Consent Form (ICF). 2. Confirmed clinical diagnosis of large duct PSC
Primary Outcome Measure
Develop 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. [ Time Frame: Quarterly for five years from enrollment ]
Central Contacts
- Stephen Rossi, PharmD3037715227
- Priya Kannusamy3037715227
Locations (11)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UC Davis | Sacramento | California | 95817 | Richard Dean Christopher Bowlus, MD (PRINCIPAL_INVESTIGATOR) |
| California Pacific Medical Center | San Francisco | California | 94109 | Kidist Yimam, MD (PRINCIPAL_INVESTIGATOR) |
| University of California, San Francisco | San Francisco | California | 94143 | Fawzy Barry Michael Li, MD, MPH (PRINCIPAL_INVESTIGATOR) |
| Yale University | New Haven | Connecticut | 06510 | Suzie Christopher Marina Silveira, MD (PRINCIPAL_INVESTIGATOR) |
| Schiff Center for Liver Diseases / University of Miami | Miami | Florida | 33136 | Cynthia Levy, MD (PRINCIPAL_INVESTIGATOR) |
| Indiana University | Indianapolis | Indiana | 46202 | Rebecca Gerstorff Craig Lammert, MD (PRINCIPAL_INVESTIGATOR) |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Vilas Patwardhan, MD (PRINCIPAL_INVESTIGATOR) |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Daniel Pratt, MD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic | Rochester | Minnesota | 55901 | Paige Powrie John Eaton, MD (PRINCIPAL_INVESTIGATOR) |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | Marlyn Mayo, MD (PRINCIPAL_INVESTIGATOR) |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | Obi Aseem, MD (PRINCIPAL_INVESTIGATOR) Velimir Luketic, MD (SUB_INVESTIGATOR) Amon Asgharpour, MD (SUB_INVESTIGATOR) Shadab Siddiqui, MD (SUB_INVESTIGATOR) |
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