Genomics of Primary Sclerosing Cholangitis (PSC)

• Sponsor: Mayo Clinic (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01161992
• Collaborator: (none)
• Enrollment: 1,500
• Location: 1
• Duration (Months): 285
• Patients Per Site Per Month: 5.3

Study Details

Study Description

Brief Summary

Primary Sclerosing Cholangitis (PSC) is a progressive liver disorder of unknown cause. Current evidence suggests that genes, the genetic material we inherit from our parents, in combination with environmental factors, likely play an important role in the development of PSC.

This study is being done to investigate whether genes make people more likely to develop PSC. Discovery of these genes will help us to better understand how PSC developes and subsequently, to apply new approaches for its prevention, diagnosis and treatment.

Condition or Disease	Intervention/Treatment	Phase
Primary Sclerosing Cholangitis (PSC)	Genetic: Genetic Analysis

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1500 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: P.R.O.G.R.E.S.S.: PSC Resource Of Genetic Risk, Environment and Synergy Studies.
• Study Start Date: Mar 1, 2002
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Outcome Measures

Primary Outcome Measures

1. Mapping of Susceptibility Genes in Adult Chronic Cholestatic Liver Diseases []

   Adult chronic cholestatic liver diseases, such as Primary Sclerosing Cholangitis (PSC), are progressive liver disorders of unknown cause. Current evidence suggests that genes, the genetic material we inherit from our parents, in combination with environmental factors, likely play an important role in the development of PSC. This study is being done to investigate whether genes (the inherited genetic material passed from parents to their children) make people more likely to develop PSC. Discovery of these proposed genes will help us to better understand how PSC progresses,

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Men, Women, and Children between the ages of 5-90 with a history of PSC.

• PSC patients who have had a liver transplant are eligible.

• Family members (1st degree relatives) of enrolled PSC patients are eligible.

Exclusion Criteria:

• Individuals with no history of PSC or those unable to provide consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55901

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Konstantinos N Lazaridis, M.D., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• P.R.O.G.R.E.S.S. PSC Resource of Genetic Risk, Environment, and Synergy Studies. Click here for more information!
• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Konstantinos N. Lazaridis, M.D., Hepatology Consultant, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT01161992
• Other Study ID Numbers: 670-02 PSC
• First Posted: Jul 14, 2010
• Last Update Posted: Jan 13, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Konstantinos N. Lazaridis, M.D., Hepatology Consultant, Mayo Clinic: Primary Sclerosing Cholangitis; PSC; Cholestatic Liver Disease
• Additional relevant MeSH terms: Cholangitis; Cholangitis, Sclerosing

Study Results

No Results Posted as of Jan 13, 2022