Genomics of Primary Sclerosing Cholangitis (PSC)

Primary Sclerosing Cholangitis (PSC) Clinical Trial

Official title:

P.R.O.G.R.E.S.S.: PSC Resource Of Genetic Risk, Environment and Synergy Studies.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01161992
• Other study ID #: 670-02 PSC
• Status: Active, not recruiting
• Start date: March 2002
• Est. completion date: December 2050

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: December 2050
• Est. primary completion date: December 2050
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Primary Sclerosing Cholangitis (PSC)

Intervention

Genetic:
• Genetic Analysis
Perform Genome Wide Association Studies.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Juran BD, Atkinson EJ, Schlicht EM, Larson JJ, Ellinghaus D, Franke A, Lazaridis KN. Genetic polymorphisms of matrix metalloproteinase 3 in primary sclerosing cholangitis. Liver Int. 2011 Jul;31(6):785-91. doi: 10.1111/j.1478-3231.2010.02420.x. Epub 2010 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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,