Genetic Epidemiology of Primary Biliary Cirrhosis (PBC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Mayo Clinic
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01161953
First received: July 12, 2010
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

Primary Biliary Cirrhosis (PBC) 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 PBC.

This study is being done to investigate whether genes make people more likely to develop PBC. Discovery of these proposed genes will help us better understand how PBC developes, and subsequently, to apply new approaches for its prevention, diagnosis and treatment.


Condition Intervention Phase
Primary Biliary Cirrhosis
Genetic: Genetic Analysis
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Understanding the Genetic Predisposition to the Development of Primary Biliary Cirrhosis (PBC).

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 Biliary Cirrhosis (PBC), 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 PBC.

    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 PBC. Discovery of these proposed genes will help us to better understand how PBC progresses, and subsequently, to apply new approaches for its prevention, diagnosis and treatment.



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)
Intervention Details:
    Genetic: Genetic Analysis
    Perform Genome Wide Association Studies.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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 PBC. 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 and women between the ages of 18-90 who have a history of PBC.
  • PBC patients who have undergone a liver transplant are eligible.
  • Family members (1st degree relatives) of enrolled PBC patients are eligible.

Exclusion Criteria:

  • Individuals with no history of PBC or those unable to provide consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01161953

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, CCRP    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
  More Information

Publications:

Responsible Party: Konstantinos N. Lazaridis M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01161953     History of Changes
Other Study ID Numbers: 670-02 PBC
Study First Received: July 12, 2010
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Primary Biliary Cirrhosis
PBC
Cholestatic Liver Disease

Additional relevant MeSH terms:
Liver Cirrhosis
Liver Cirrhosis, Biliary
Bile Duct Diseases
Biliary Tract Diseases
Cholestasis
Cholestasis, Intrahepatic
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on October 21, 2014