Primary Sclerosing CholangitisPSCNCT03041662
Surveillance Study for Early Detection of Cholangiocarcinoma (CCA) in Primary Sclerosing Cholangitis (PSC)
An observational study of Primary Sclerosing Cholangitis and Cholangiocarcinoma, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
This observational study of a national cohort of 600 Swedish PSC patients include yearly MR/MRCP, biobanking of serum, plasma and blood, followup clinical data (interventions, symptoms, labs, colonoscopy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Sclerosing Cholangitis, Cholangiocarcinoma
- What is being tested?
- MR/MRCP
- How many people
- 620 participants
- Where
- 1 siteSweden
- Study dates
- 31 Oct 2011to 30 Nov 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: National Swedish cohort of PSC patients followed at 14 hospitals
Who may be able to join
- Diagnosis of PSC by MR/MRCP
- Life expectancy >1 year
- Informed consent
Who cannot join
- Liver transplantation or on the waiting list
- Secondry SC
- Diagnosis of CCA
Trial locations and contacts
1 site in 1 country.
About this study
This observational study of a national cohort of 600 Swedish PSC patients include yearly MR/MRCP, biobanking of serum, plasma and blood, followup clinical data (interventions, symptoms, labs, colonoscopy). The aim is to collect a well characterized cohort of PSC patients and provide future possibilities to evaluate biomarkers for prognosis and early cancer detection.
- Conditions
- Primary Sclerosing Cholangitis, Cholangiocarcinoma
- Being tested
- MR/MRCP
- 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.
MR/MRCPDiagnostic test
MR/MRCP
What is being measured
The primary outcome is the main question the study is designed to answer.
cholangiocarcinoma
cholangiocarcinoma
Measured: 10 yrs f-up
liver transplatation
liver transplatation
Measured: 10 yrs f-up
death
death
Measured: 10 yrs f-up
Secondary outcomes (1)
biliary dysplasia
biliary dysplasia
Measured: 10 yrs f-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start31 Oct 2011
- Primary completion31 Oct 2016
- Study completion30 Nov 2020
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 Karolinska University 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
- Prospective
- Enrolment
- 620 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annika Bergquist, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041662
- Sponsor's protocol ID
- 2011/2:6
- Acronym
- PSC
- Status last verified
- Sep 2021
- First submitted
- 1 Feb 2017
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance Study for Early Detection of Cholangiocarcinoma (CCA) in Primary Sclerosing Cholangitis (PSC)
- ClinicalTrials.gov ID
- NCT03041662
- Acronym / sponsor ID
- PSC / 2011/2:6
- Conditions
- Primary Sclerosing Cholangitis, Cholangiocarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 620 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 31 Oct 2011 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 3 Feb 2017 (estimated)
- 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 observational study of a national cohort of 600 Swedish PSC patients include yearly MR/MRCP, biobanking of serum, plasma and blood, followup clinical data (interventions, symptoms, labs, colonoscopy). The aim is to collect a well characterized cohort of PSC patients and provide future possibilities to evaluate biomarkers for prognosis and early cancer detection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- National Swedish cohort of PSC patients followed at 14 hospitals
Key inclusion criteria (3 listed)
- Diagnosis of PSC by MR/MRCP
- Life expectancy >1 year
- Informed consent
Key exclusion criteria (3 listed)
- Liver transplantation or on the waiting list
- Secondry SC
- Diagnosis of CCA
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 |
|---|---|---|
| MR/MRCPMR/MRCP | Diagnostic test | – |
Primary outcome
cholangiocarcinoma
Time frame: 10 yrs f-up
cholangiocarcinoma
liver transplatation
Time frame: 10 yrs f-up
liver transplatation
death
Time frame: 10 yrs f-up
death
1 secondary outcome
biliary dysplasia
Time frame: 10 yrs f-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Cholangiocarcinoma, run by Karolinska University Hospital at 1 site in Sweden.
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: finished, as of the sponsor's last update on 16 Sep 2021. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cholangiocarcinoma (time frame: 10 yrs f-up). The study lists 3 primary outcomes in all. 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 16 Sep 2021.