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Genetic Epidemiology of Primary Biliary Cirrhosis (PBC)

This study is currently recruiting participants.
Verified August 2017 by Konstantinos N. Lazaridis, M.D., Mayo Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT01161953
First Posted: July 14, 2010
Last Update Posted: August 22, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Konstantinos N. Lazaridis, M.D., Mayo Clinic
  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
Primary Biliary Cirrhosis Genetic: Genetic Analysis

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Other
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 Konstantinos N. Lazaridis, M.D., Mayo Clinic:

Primary Outcome Measures:
  • Mapping of Susceptibility Genes in Adult Chronic Cholestatic Liver Diseases

    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
Blood and stool samples are 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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 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
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): 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., Hepatology Consultant, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01161953     History of Changes
Other Study ID Numbers: 670-02 PBC
First Submitted: July 12, 2010
First Posted: July 14, 2010
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 Biliary Cirrhosis
PBC
Cholestatic Liver Disease

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