Genomics of Primary Sclerosing Cholangitis (PSC)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Primary Sclerosing Cholangitis (PSC) |
Genetic: Genetic Analysis |
Phase 1 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort |
| Official Title: | P.R.O.G.R.E.S.S.: PSC Resource Of Genetic Risk, Environment and Synergy Studies. |
- Mapping of Susceptibility Genes in Adult Chronic Cholestatic Liver Diseases [ Time Frame: UNKNOWN ] [ Designated as safety issue: No ]
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
Whole blood and serum is collected
| Estimated Enrollment: | 1500 |
| Study Start Date: | March 2002 |
| Estimated Study Completion Date: | December 2025 |
| Estimated Primary Completion Date: | December 2025 (Final data collection date for primary outcome measure) |
-
Genetic: Genetic Analysis
Eligibility| Ages Eligible for Study: | 5 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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| Contact: Erik M Schlicht C.C.R.P. | 507-284-4312 | schlicht.erik@mayo.edu |
| 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. | |
| Principal Investigator: | Konstantinos N Lazaridis, M.D. | Mayo Clinic |
More Information
Additional Information:
Publications:
| Responsible Party: | Konstantinos Lazaridis, M.D., Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01161992 History of Changes |
| Other Study ID Numbers: | 670-02 PSC |
| Study First Received: | July 12, 2010 |
| Last Updated: | February 26, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on May 19, 2013