Primary Sclerosing CholangitisNCT04753996
Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients
An observational study of Primary Sclerosing Cholangitis and PSC, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to create a collection of bile, bile duct brushings and medical information from people with Primary Sclerosing Cholangitis (PSC) and controls to learn more about changes that occur in the liver. 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, PSC, Cholangiocarcinoma
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2021to 1 Jan 2035
- 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: Subjects with Primary Sclerosing Cholangitis (PSC) and controls without PSC will be able to participate in this study.
Who may be able to join
- PSC
- Patients diagnosed with PSC between the age of 18 and 85.
- 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.
- 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. Patients with PSC and Cholangiocarcinoma will be included.
- Controls
- Controls without history of PSC or evidence of other chronic liver disease of either gender that will participate in this study should be between the ages of 18-85.
Who cannot join
- Patients unable to provide inform consent.
- Prisoners and institutionalized individuals.
- PSC with orthotopic liver transplantation
- History of Roux En Y procedure
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 in Rochester
Rochester, Minnesota, 55905
Erik M Schlicht, B.A.,CCRP, 507-284-4312, schlicht.erik@mayo.edu
Jackie Bianchi, 507-266-0346, bianchi.jackie@mayo.edu
About this study
The purpose of this research is to create a collection of bile, bile duct brushings and medical information from people with Primary Sclerosing Cholangitis (PSC) and controls to learn more about changes that occur in the liver.
Read the detailed description
The study will ask participants to provide bile and/or bile duct cytology brushings at time of endoscopic retrograde cholangiopancreatography (ERCP) or cholecystectomy (gallbladder removal). The bile and brushings will be used to generate and perpetuate bile-derived organoids using an established matrigel-based protocol. These organoids will then be used in downstream experiments to better understand disease-specific alterations to biological pathways informative of disease pathogenesis
- Conditions
- Primary Sclerosing Cholangitis, PSC, Cholangiocarcinoma
- Medical subject headings
- Cholangitis, Sclerosing, Cholangiocarcinoma
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 (PSC) | Subjects diagnosed with Primary Sclerosing Cholangitis (PSC) will be asked to provide bile and/or brush cytology at time of endoscopic retrograde cholangiopancreatography (ERCP) or cholecystectomy (gallbladder removal). | |
| Control (non-PSC) | Subjects without a diagnosis of Primary Sclerosing Cholangitis (PSC) will be asked to provide bile and/or brush cytology at time of endoscopic retrograde cholangiopancreatography (ERCP) or cholecystectomy (gallbladder removal). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants in study.
Number of participants in study.
Measured: 20 years
Secondary outcomes (2)
Number of samples (per type)
Number of samples collected (bile liquid, biliary cells)
Measured: 20 years
Number of clinical phenotypes and/or observations.
Number of clinical phenotypes and/or endpoints observed (i.e. disease progression, liver ca development, organoids.)
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 posted15 Feb 2021
- Study start8 Mar 2021
- Primary completion1 Jan 2035 (estimated)
- Study completion1 Jan 2035 (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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
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, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753996
- Sponsor's protocol ID
- 20-012867
- Other IDs
- RC2DK118619
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2021
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients
- ClinicalTrials.gov ID
- NCT04753996
- Acronym / sponsor ID
- 20-012867
- Conditions
- Primary Sclerosing Cholangitis, PSC, Cholangiocarcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 1 Jan 2035 (estimated)
- Study completion
- 1 Jan 2035 (estimated)
- First posted
- 15 Feb 2021 (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.
The purpose of this research is to create a collection of bile, bile duct brushings and medical information from people with Primary Sclerosing Cholangitis (PSC) and controls to learn more about changes that occur in the liver.
Detailed description
The study will ask participants to provide bile and/or bile duct cytology brushings at time of endoscopic retrograde cholangiopancreatography (ERCP) or cholecystectomy (gallbladder removal). The bile and brushings will be used to generate and perpetuate bile-derived organoids using an established matrigel-based protocol. These organoids will then be used in downstream experiments to better understand disease-specific alterations to biological pathways informative of disease pathogenesis
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Sclerosing Cholangitis (PSC) | – | –Subjects diagnosed with Primary Sclerosing Cholangitis (PSC) will be asked to provide bile and/or brush cytology at time of endoscopic retrograde cholangiopancreatography (ERCP) or cholecystectomy (gallbladder removal). |
| Control (non-PSC) | – | –Subjects without a diagnosis of Primary Sclerosing Cholangitis (PSC) will be asked to provide bile and/or brush cytology at time of endoscopic retrograde cholangiopancreatography (ERCP) or cholecystectomy (gallbladder removal). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with Primary Sclerosing Cholangitis (PSC) and controls without PSC will be able to participate in this study.
Key inclusion criteria (6 listed)
- PSC
- Patients diagnosed with PSC between the age of 18 and 85.
- 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.
- 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. Patients with PSC and Cholangiocarcinoma will be included.
- Controls
Key exclusion criteria (4 listed)
- Patients unable to provide inform consent.
- Prisoners and institutionalized individuals.
- PSC with orthotopic liver transplantation
- History of Roux En Y procedure
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 study.
Time frame: 20 years
Number of participants in study.
2 secondary outcomes
Number of samples (per type)
Time frame: 20 years
Number of clinical phenotypes and/or observations.
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.
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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, MD 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 PSC, 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 6 inclusion and 4 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 ((507) 284-4212, 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 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.