Primary Sclerosing CholangitisNCT05463445
Multicenter Observational Study of PSC and IgG4-SC in China
An observational study of Primary Sclerosing Cholangitis and IgG4-related Sclerosing Cholangitis, run by RenJi Hospital at 1 site in China.
Trial summary
The investigators aimed to collect demographic features and clinical outcomes in patients diagnosed with PSC and IgG4-SC by utilizing participants database from multiple medical centers across Mainland China. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Primary Sclerosing Cholangitis, IgG4-related Sclerosing Cholangitis
- What is being tested?
- Only observation
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: This program will be conducted in multiple medical centers among the major cities across Mainland China. The sample size of subjects will be 1000, including 500 patients with PSC and 500 patients with IgG4-SC.
Who may be able to join
- Age above 18 years old,
- Male or Female,
- Patients admitted in our medical centers which met the PSC criteria according to The European Association for the Study of the Liver Clinical Practice Guidelines "Management of cholestatic liver diseases" in 2009; or patients diagnosed with IgG4-SC which met initially using the Japan Pancreas Society criteria and confirmed using HISORt criteria.
Who cannot join
- Female subjects who is pregnant, breastfeeding or is considering being pregnant during the study;
- History of other malignancies, including hematological tumors, solid tumors except hepatobiliary system;
- History of infectious diseases, including hepatis A, B, C, E and tuberculosis.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
RenJi Hospital
Shanghai, Shanghai Municipality, 200001
Min Lian, MD, PhD, +8615800744783, sophialian24@163.com
Xiong Ma, MD, PhD
About this study
Official title: Multicenter Study of Clinical Characteristics and Management of Primary Sclerosing Cholangitis and IgG4-related Sclerosing Cholangitis in China.
The investigators aimed to collect demographic features and clinical outcomes in patients diagnosed with PSC and IgG4-SC by utilizing participants database from multiple medical centers across Mainland China. Cross-sectional studies will focus on characterizing clinical presentations and validating diagnostic and prognostic models on Chinese PSC and IgG4-SC patients.
- Being tested
- Only observation
- Medical subject headings
- Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Only observationOther
No intervention is needed.
| Study group | Role | What they receive |
|---|---|---|
| A | patients diagnosed with Primary Sclerosing Cholangitis which met the PSC criteria according to The European Association for the Study of the Liver Clinical Practice Guidelines "Management of cholestatic liver diseases" in 2009. Receives: Other: Only observation | |
| B | patients diagnosed with IgG4-related Sclerosing Cholangitis which met initially using the Japan Pancreas Society criteria and confirmed using HISORt criteria. Receives: Other: Only observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of new occurrence of decompensated liver related events, malignancies, liver transplantation and liver-related death caused by PSC and IgG4-SC
describe the characteristics and clinical outcomes of PSC and IgG4-SC patients among multiple medical centers in China
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Jul 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jul 2023 (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 RenJi HospitalThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ma xiong, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463445
- Sponsor's protocol ID
- SC2022CH001
- Status last verified
- Jul 2022
- First submitted
- 14 Jul 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After this observational study is recruited, we are welcome to share the basic demographics and clinical outcomes of recruited IPD.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of Clinical Characteristics and Management of Primary Sclerosing Cholangitis and IgG4-related Sclerosing Cholangitis in China.
- ClinicalTrials.gov ID
- NCT05463445
- Acronym / sponsor ID
- SC2022CH001
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 19 Jul 2022 (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 investigators aimed to collect demographic features and clinical outcomes in patients diagnosed with PSC and IgG4-SC by utilizing participants database from multiple medical centers across Mainland China. Cross-sectional studies will focus on characterizing clinical presentations and validating diagnostic and prognostic models on Chinese PSC and IgG4-SC patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: Only observationpatients diagnosed with Primary Sclerosing Cholangitis which met the PSC criteria according to The European Association for the Study of the Liver Clinical Practice Guidelines "Management of cholestatic liver diseases" in 2009. |
| B | – | Other: Only observationpatients diagnosed with IgG4-related Sclerosing Cholangitis which met initially using the Japan Pancreas Society criteria and confirmed using HISORt criteria. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This program will be conducted in multiple medical centers among the major cities across Mainland China. The sample size of subjects will be 1000, including 500 patients with PSC and 500 patients with IgG4-SC.
Key inclusion criteria (3 listed)
- Age above 18 years old,
- Male or Female,
- Patients admitted in our medical centers which met the PSC criteria according to The European Association for the Study of the Liver Clinical Practice Guidelines "Management of cholestatic liver diseases" in 2009; or patients diagnosed with IgG4-SC which met initially using the Japan Pancreas Society criteria and confirmed using HISORt criteria.
Key exclusion criteria (3 listed)
- Female subjects who is pregnant, breastfeeding or is considering being pregnant during the study;
- History of other malignancies, including hematological tumors, solid tumors except hepatobiliary system;
- History of infectious diseases, including hepatis A, B, C, E and tuberculosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Only observationNo intervention is needed. | Other | A, B |
Primary outcome
The percentage of new occurrence of decompensated liver related events, malignancies, liver transplantation and liver-related death caused by PSC and IgG4-SC
Time frame: 1 year
describe the characteristics and clinical outcomes of PSC and IgG4-SC patients among multiple medical centers in China
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: No. After this observational study is recruited, we are welcome to share the basic demographics and clinical outcomes of recruited IPD.
Related trials for Primary Sclerosing Cholangitis
RecruitingObservational study
Unraveling the Mechanisms Underlying Primary Sclerosing Cholangitis Through a Multidisciplinary, Integrative Research Approach
Primary Sclerosing Cholangitis
Not yet recruitingPhase 2
FEAST and HOPE: Redox PSC Pilot Study
Primary Sclerosing Cholangitis (PSC)
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
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. This study is not recruiting at the moment.
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 IgG4-related Sclerosing Cholangitis, run by RenJi Hospital at 1 site in China.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Jul 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Lian, MD, PhD (+8615800744783, sophialian24@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of new occurrence of decompensated liver related events, malignancies, liver transplantation and liver-related death caused by PSC and IgG4-SC (time frame: 1 year). 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 19 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.