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Genomics of Primary Sclerosing Cholangitis (PSC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01161992
Recruitment Status : Active, not recruiting
First Posted : July 14, 2010
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Konstantinos N. Lazaridis, M.D., Mayo Clinic

Tracking Information
First Submitted Date July 12, 2010
First Posted Date July 14, 2010
Last Update Posted Date December 11, 2018
Study Start Date March 2002
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 26, 2013)
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,
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01161992 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Genomics of Primary Sclerosing Cholangitis (PSC)
Official Title P.R.O.G.R.E.S.S.: PSC Resource Of Genetic Risk, Environment and Synergy Studies.
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
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.
Condition Primary Sclerosing Cholangitis (PSC)
Intervention Genetic: Genetic Analysis
Perform Genome Wide Association Studies.
Study Groups/Cohorts Not Provided
Publications * 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 Dec 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: February 26, 2013)
1500
Original Enrollment Not Provided
Estimated Study Completion Date December 2025
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 90 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01161992
Other Study ID Numbers 670-02 PSC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Konstantinos N. Lazaridis, M.D., Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators Not Provided
Investigators
Principal Investigator: Konstantinos N Lazaridis, M.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date December 2018