Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
9150 participants
OBSERVATIONAL
2017-01-31
2050-01-31
Brief Summary
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Detailed Description
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Blood, saliva, stool, and urine 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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Primary Sclerosing Cholangitis
Patients with a diagnosis of primary sclerosing cholangitis (PSC).
No interventions assigned to this group
Primary Biliary Cirrhosis/Cholangitis
Patients with a diagnosis of primary biliary cirrhosis (PBC).
No interventions assigned to this group
Control group 1
Patients who do not have PBC or PSC but do have another form of chronic liver disease.
No interventions assigned to this group
Control group 2
Patients without liver disease.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
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
18 Years
85 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Konstantinos N. Lazaridis, M.D.
Principal Investigator
Principal Investigators
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Konstantinos Lazaridis, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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16-005892
Identifier Type: -
Identifier Source: org_study_id
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