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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 : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Konstantinos N. Lazaridis, M.D., Mayo Clinic

Tracking Information
First Submitted Date February 14, 2017
First Posted Date February 26, 2018
Last Update Posted Date March 6, 2019
Study Start Date January 2017
Estimated Primary Completion Date January 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 22, 2018)
Number of participants in the study. [ Time Frame: 20 years ]
Number of participants in the study.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03445585 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 22, 2018)
  • 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biobank for Cholestatic Liver Diseases.
Official Title A Resource of Blood and Other Biospecimens of Patients With Cholestatic Liver Disease and Unaffected Individuals
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).
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]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 20 Years
Biospecimen Retention:   Samples With DNA
Description:
This study will collect bile and bile duct cells during ERCP procedures, residual liver tissue from liver transplants, blood, stool, and urine.
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.
Condition
  • Primary Sclerosing Cholangitis
  • Primary Biliary Cirrhosis
  • Cholangiocarcinoma
  • Liver Cancer
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: February 22, 2018)
5000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2030
Estimated Primary Completion Date January 2030   (Final data collection date for primary outcome measure)
Eligibility 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 with orthotopic liver transplantation
  • History of chemotherapy treatment
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03445585
Other Study ID Numbers 16-005892
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Konstantinos N. Lazaridis, M.D., Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators Not Provided
Investigators
Principal Investigator: Konstantinos Lazaridis, M.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date March 2019