Primary Sclerosing CholangitisNCT03445585
Biobank for Cholestatic Liver Diseases.
An observational study of Primary Sclerosing Cholangitis and Primary Biliary Cirrhosis, run by Mayo Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis, Cholangiocarcinoma
- How many people
- 9,150 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Jan 2050
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 14Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55901
Erik M Schlicht, CCRP, 507-284-4312, schlicht.erik@mayo.edu
Konstantinos N Lazaridis, M.D.
About this study
Official title: A Resource of Blood and Other Biospecimens of Patients With Cholestatic Liver Disease and Unaffected Individuals
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).
Read the 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.
- Conditions
- Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis, Cholangiocarcinoma, Liver Cancer
- Medical subject headings
- Cholangitis, Sclerosing, Liver Cirrhosis, Biliary, Cholangiocarcinoma, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants in the study.
Number of participants in the study.
Measured: 20 years
Secondary outcomes (2)
Number of samples collected (per type).
Number of samples collected (blood, urine, stool, bile, bile duct cells)
Measured: 20 years
Number of clinical phenotypes and/or endpoints observed (per category)
Number of clinical phenotypes and/or endpoints observed (i.e. disease progression, liver cancer development)
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study startJan 2017
- Primary completionJan 2050 (estimated)
- Study completionJan 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sclerosing CholangitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 9,150 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos N. Lazaridis, M.D., Mayo Clinic
- Investigators
- Konstantinos Lazaridis, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445585
- Sponsor's protocol ID
- 16-005892
- Status last verified
- Feb 2026
- First submitted
- 14 Feb 2017
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Resource of Blood and Other Biospecimens of Patients With Cholestatic Liver Disease and Unaffected Individuals
- ClinicalTrials.gov ID
- NCT03445585
- Acronym / sponsor ID
- 16-005892
- Conditions
- Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis, Cholangiocarcinoma, Liver Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 9,150 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2050 (estimated)
- Study completion
- Jan 2050 (estimated)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants in the study.
Time frame: 20 years
Number of participants in the study.
2 secondary outcomes
Number of samples collected (per type).
Time frame: 20 years
Number of clinical phenotypes and/or endpoints observed (per category)
Time frame: 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Primary Sclerosing Cholangitis
RecruitingPhase 3
A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis
Primary Sclerosing Cholangitis
Active, not recruitingPhase 2
A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.
Primary Sclerosing Cholangitis
Active, not recruitingPhase 2
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
Primary Sclerosing Cholangitis
RecruitingObservational study
Unraveling the Mechanisms Underlying Primary Sclerosing Cholangitis Through a Multidisciplinary, Integrative Research Approach
Primary Sclerosing Cholangitis
Not yet recruitingObservational study
PET/MRI of Primary Sclerosing Cholangitis
PSC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Konstantinos Lazaridis, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Sclerosing Cholangitis and Primary Biliary Cirrhosis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erik Schlicht, CCRP, B.A. (507-284-4312, schlicht.erik@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants in the study. (time frame: 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.