Genetic Epidemiology of Primary Biliary Cirrhosis (PBC)
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ClinicalTrials.gov Identifier: NCT01161953 |
Recruitment Status
:
Recruiting
First Posted
: July 14, 2010
Last Update Posted
: August 22, 2017
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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 or disease | Intervention/treatment |
---|---|
Primary Biliary Cirrhosis | Genetic: Genetic Analysis |
Study Type : | Observational |
Estimated Enrollment : | 1500 participants |
Observational Model: | Family-Based |
Time Perspective: | Other |
Official Title: | Understanding the Genetic Predisposition to the Development of Primary Biliary Cirrhosis (PBC). |
Study Start Date : | March 2002 |
Estimated Primary Completion Date : | December 2025 |
Estimated Study Completion Date : | December 2025 |

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Genetic: Genetic Analysis
- 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

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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 |
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.

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
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, CCRP 507-284-4312 schlicht.erik@mayo.edu | |
Principal Investigator: Konstantinos N Lazaridis, M.D. |
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: | NCT01161953 History of Changes |
Other Study ID Numbers: |
670-02 PBC |
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 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 |