Genomics of Primary Sclerosing Cholangitis (PSC)

March 14, 2024 updated by: Konstantinos N. Lazaridis, M.D., Mayo Clinic

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55901
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects who are patients at Mayo Clinic and are seen in the department of Gastroenterology and Hepatology are recruited by mail and carry a diagnosis of Primary Sclerosing Cholangitis (PSC). Subjects who are not Mayo Clinic patients are encouraged to contact the study coordinator by phone or email to request enrollment.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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,

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Estimated)

December 1, 2050

Study Completion (Estimated)

December 1, 2050

Study Registration Dates

First Submitted

July 12, 2010

First Submitted That Met QC Criteria

July 12, 2010

First Posted (Estimated)

July 14, 2010

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 670-02 PSC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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