Cholangiocarcinoma, Liver Cancer, Primary Biliary Cirrhosis, Primary Sclerosing Cholangitis
Conditions
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, saliva, stool, and urine samples will be collected periodically during patient visits, mail-home kit (collected locally), or via remote phlebotomy at a place directed by the subject. Bile and bile duct cells will be collected during clinically necessary Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures being performed at Mayo Clinic for clinical reasons. 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.
Interventions
None listed
Sponsors
Mayo Clinic
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants in the study. | 20 years | Number of participants in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of samples collected (per type). | 20 years | Number of samples collected (blood, urine, stool, bile, bile duct cells) |
| Number of clinical phenotypes and/or endpoints observed (per category) | 20 years | Number of clinical phenotypes and/or endpoints observed (i.e. disease progression, liver cancer development) |
Countries
United States
Contacts
CONTACTErik Schlicht, CCRP, B.A.
CONTACTJackie Bianchi
PRINCIPAL_INVESTIGATORKonstantinos Lazaridis, M.D.
Mayo Clinic
Outcome results
None listed