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Biobank for Cholestatic Liver Diseases.

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ClinicalTrials.gov Identifier: NCT03445585
Recruitment Status : Enrolling by invitation
First Posted : February 26, 2018
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Konstantinos N. Lazaridis, M.D., Mayo Clinic

Brief Summary:
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).

Condition or disease
Primary Sclerosing Cholangitis Primary Biliary Cirrhosis Cholangiocarcinoma Liver Cancer

Detailed Description:

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
Observational Model: Other
Time Perspective: Prospective
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


Group/Cohort
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.



Primary Outcome Measures :
  1. Number of participants in the study. [ Time Frame: 20 years ]
    Number of participants in the study.


Secondary Outcome Measures :
  1. Number of samples collected (per type). [ Time Frame: 20 years ]
    Number of samples collected (blood, urine, stool, bile, bile duct cells)

  2. 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
This study will collect bile and bile duct cells during ERCP procedures, residual liver tissue from liver transplants, blood, stool, and urine.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with PBC, PSC, controls without liver disease, and with other chronic liver disease without history of PBC or PSC seen or followed at Mayo Clinic will be invited to participate in this study.
Criteria

Inclusion Criteria:

PSC

  • Patients diagnosed with PSC and who are between the age of 18 and 85 at time of enrollment in the study.
  • The diagnosis of PSC will be based on standard PSC criteria including clinical and biochemical evidence of chronic cholestasis of at least six months duration, positive cholangiographic findings, and compatible liver biopsies if available.
  • Patients with PSC who have undergone orthotopic liver transplantation will be offered enrollment except for collection of bile - please see below under Exclusion Criteria.
  • Women with PSC of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation.

PBC

  • Patients diagnosed with PBC and who are between the age of 18 and 85 at time of enrollment in the study.
  • The diagnosis of PBC will be based on standard PBC criteria including clinical and biochemical evidence of chronic cholestasis of at least six month duration, positive anti-mitochondrial antibodies in serum and compatible liver biopsies, if available.
  • Patients with PBC who have undergone orthotopic liver transplantation will be offered enrollment except for collection of bile - please see below under Exclusion Criteria.
  • Women with PBC of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation.

Controls

  • Controls without history of PBC, PSC, or evidence of other chronic liver disease of either gender that participate in this study will be between the ages of 18 and 85.

Liver Disease Controls

  • Patients without history of PBC or PSC but do have evidence of other chronic liver disease of either gender will be offered participation in this study if between the ages of 18 and 85.

Exclusion Criteria (all subjects):

  • PBC or PSC patients with known and overlapping other chronic liver diseases
  • Patients unable to provide informed consent
  • Prisoners and institutionalized individuals

Exclusion Criteria (for bile collection during ERCP)

  • PSC patients with biliary stents in place
  • PSC with orthotopic liver transplantation

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): NCT03445585


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55901
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Konstantinos Lazaridis, M.D. Mayo Clinic

Responsible Party: Konstantinos N. Lazaridis, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03445585     History of Changes
Other Study ID Numbers: 16-005892
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Liver Diseases
Liver Neoplasms
Cholangiocarcinoma
Cholangitis
Cholangitis, Sclerosing
Liver Cirrhosis, Biliary
Cholestasis
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bile Duct Diseases
Biliary Tract Diseases
Cholestasis, Intrahepatic
Liver Cirrhosis