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Trial record 8 of 25 for:    Recruiting Studies | Primary Sclerosing Cholangitis

Genomics of Primary Sclerosing Cholangitis (PSC)

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ClinicalTrials.gov Identifier: NCT01161992
Recruitment Status : Recruiting
First Posted : July 14, 2010
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Konstantinos N. Lazaridis, M.D., Mayo Clinic

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
Primary Sclerosing Cholangitis (PSC) Genetic: Genetic Analysis

Study Type : Observational
Estimated 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 : March 2002
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025



Intervention Details:
  • Genetic: Genetic Analysis
    Perform Genome Wide Association Studies.


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,



Biospecimen Retention:   Samples With DNA
Blood sample will be drawn at local facility and sent to Mayo Clinic by mail. Stool sample will be collected and sent back to Mayo Clinic by mail. All study related charges will be charged to the study.


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01161992


Contacts
Contact: Erik M Schlicht C.C.R.P. 507-284-4312 schlicht.erik@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55901
Contact: Erik M Schlicht    507-284-4312    schlicht.erik@mayo.edu   
Principal Investigator: Konstantinos N Lazaridis, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Konstantinos N Lazaridis, M.D. Mayo Clinic

Publications of Results:
Responsible Party: Konstantinos N. Lazaridis, M.D., Hepatology Consultant, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01161992     History of Changes
Other Study ID Numbers: 670-02 PSC
First Posted: July 14, 2010    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Konstantinos N. Lazaridis, M.D., Mayo Clinic:
Primary Sclerosing Cholangitis
PSC
Cholestatic Liver Disease

Additional relevant MeSH terms:
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases