NCT03445585

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,150

participants targeted

Target at P75+ for all trials

Timeline
288mo left

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Jan 2017Jan 2050

Study Start

First participant enrolled

January 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2017

Completed
1 year until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
31.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2050

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2050

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

33 years

First QC Date

February 14, 2017

Last Update Submit

February 12, 2026

Conditions

Primary Sclerosing CholangitisPrimary Biliary CirrhosisCholangiocarcinomaLiver Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of participants in the study.

    Number of participants in the study.

    20 years

Secondary Outcomes (2)

  • Number of samples collected (per type).

    20 years

  • Number of clinical phenotypes and/or endpoints observed (per category)

    20 years

Study Arms (4)

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.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • PBC or PSC patients with known and overlapping other chronic liver diseases
  • Patients unable to provide informed consent
  • Prisoners and institutionalized individuals
  • PSC with orthotopic liver transplantation
  • History of Roux en Y

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55901, United States

RECRUITING

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.

MeSH Terms

Conditions

Cholangitis, SclerosingLiver Cirrhosis, BiliaryCholangiocarcinomaLiver Neoplasms

Condition Hierarchy (Ancestors)

CholangitisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesCholestasis, IntrahepaticCholestasisLiver DiseasesLiver CirrhosisFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by Site

Study Officials

  • Konstantinos Lazaridis, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erik Schlicht, CCRP, B.A.

CONTACT

507-284-4312schlicht.erik@mayo.edu

Jackie Bianchi

CONTACT

507-266-0346bianchi.jackie@mayo.edu

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 14, 2017

First Posted

February 26, 2018

Study Start

January 1, 2017

Primary Completion (Estimated)

January 1, 2050

Study Completion (Estimated)

January 1, 2050

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)