Biobank for Cholestatic Liver Diseases.
|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: NCT03445585|
Recruitment Status : Enrolling by invitation
First Posted : February 26, 2018
Last Update Posted : February 26, 2018
|Condition or disease|
|Primary Sclerosing Cholangitis Primary Biliary Cirrhosis Cholangiocarcinoma Liver Cancer|
This study is a biobank of specimens and clinical data for use in current and future research to better understand the cholestatic liver diseases primary biliary cirrhosis/cholangitis (PBC) and primary sclerosing cholangitis (PSC).
Blood, urine, and stool samples will be collected periodically during patient visits or via a mail-home kit. Bile and bile duct cells will be collected during clinically necessary Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures. Anticipated research will focus on multi-omics assessments of biospecimens to better define how these diseases start and progress in order to develop novel tests for early detection of complication and better disease prognostication.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||5000 participants|
|Target Follow-Up Duration:||20 Years|
|Official Title:||A Resource of Blood and Other Biospecimens of Patients With Cholestatic Liver Disease and Unaffected Individuals|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||January 2030|
|Estimated Study Completion Date :||January 2030|
Primary Sclerosing Cholangitis
Patients with a diagnosis of primary sclerosing cholangitis (PSC).
Primary Biliary Cirrhosis/Cholangitis
Patients with a diagnosis of primary biliary cirrhosis (PBC).
Control group 1
Patients who do not have PBC or PSC but do have another form of chronic liver disease.
Control group 2
Patients without liver disease.
- Number of participants in the study. [ Time Frame: 20 years ]Number of participants in the study.
- Number of samples collected (per type). [ Time Frame: 20 years ]Number of samples collected (blood, urine, stool, bile, bile duct cells)
- Number of clinical phenotypes and/or endpoints observed (per category) [ Time Frame: 20 years ]Number of clinical phenotypes and/or endpoints observed (i.e. disease progression, liver cancer development)
Biospecimen Retention: Samples With DNA
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): NCT03445585
|United States, Minnesota|
|Rochester, Minnesota, United States, 55901|
|Principal Investigator:||Konstantinos Lazaridis, M.D.||Mayo Clinic|