PSVD With or Without SScNCT06032754
PortoSinusoidal Vascular Diseases and Systemic Sclerosis
An observational study of PSVD With or Without SSc, run by University Hospital, Caen at 1 site in France.
Trial summary
Porto-Sinusoidal Vascular Disorders (PSVD) is a heterogeneous clinico-pathological entity characterized by alterations in small liver vessels. "Nodular regenerative hyperplasia (NRH)" is the most common PSVD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PSVD With or Without SSc
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2023to 29 Mar 2024
- 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: 3 types of patients : PSVD with SSC, PSVD without SSC, SSC without PSVD will be compared.
Who may be able to join
- PSVD (Valdig criteria)
- SSC (ACR/EULAR 2013 criteria)
Who cannot join
- Liver cirrhosis
- Limited scleroderma
- Autoimmune hepatitis
- Primary biliary cholangitis
Trial locations and contacts
1 site in 1 country.
About this study
Porto-Sinusoidal Vascular Disorders (PSVD) is a heterogeneous clinico-pathological entity characterized by alterations in small liver vessels. "Nodular regenerative hyperplasia (NRH)" is the most common PSVD. The most frequent liver disease associated with Systemic sclerosis (SSc) is primary biliary cholangitis reported in 2 to 22% of cases. NRH prevalence estimated to 1.4%, may be underestimated as NRH diagnosis is histologic and usually suspected in case of complications due to portal hypertension. Few data are available about NRH associated with SSc resulting in a lack of knowledge of the characteristics and outcome of these patients.
Read the detailed description
The study aims to compare the outcome of patients with MVPS associated with SSc to patients with MVPS without SSc. This work is a multicenter retrospective study comparing two groups of adult patients, one with MVPS associated with SSc and the other with MVPS without SSc. Patients with MVPS associated with SSc will be recruited from French university hospital departments of Hepatogastroenterology and Internal Medecine. Patients with MVPS without SSc will be recruited from the Beaujon Hospital database dedicated to liver vascular diseases.
- Conditions
- PSVD With or Without SSc
- Keywords
- Porto-Sinusoidal Vascular Disease, Nodular regenerative hyperplasia, Systemic sclerosis
- Medical subject headings
- Idiopathic Noncirrhotic Portal Hypertension, Scleroderma, Systemic
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 |
|---|---|---|
| First group : SSC with PSVD | medical file analysis of patients affected by SSC and PSVD | |
| Second group : PSVD without SSC | medical file analysis of patients affected by PSVD only | |
| Third group : SSC without PSVD | medical file analysis of patients affected by SSC only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognosis
To compare prognosis of PSVD patients with or without SSc (less or more gastrointestinal bleeding/portal vein thrombosis)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Feb 2023
- Primary completion29 Mar 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PSVD With or Without SScStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032754
- Sponsor's protocol ID
- MVPScS
- Status last verified
- Mar 2024
- First submitted
- 5 Sep 2023
- Last updated
- 20 Jun 2024
- 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 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PortoSinusoidal Vascular Diseases and Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT06032754
- Acronym / sponsor ID
- MVPScS
- Conditions
- PSVD With or Without SSc
- Keywords
- Porto-Sinusoidal Vascular Disease, Nodular regenerative hyperplasia, Systemic sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 13 Sep 2023 (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.
Porto-Sinusoidal Vascular Disorders (PSVD) is a heterogeneous clinico-pathological entity characterized by alterations in small liver vessels. "Nodular regenerative hyperplasia (NRH)" is the most common PSVD. The most frequent liver disease associated with Systemic sclerosis (SSc) is primary biliary cholangitis reported in 2 to 22% of cases. NRH prevalence estimated to 1.4%, may be underestimated as NRH diagnosis is histologic and usually suspected in case of complications due to portal hypertension. Few data are available about NRH associated with SSc resulting in a lack of knowledge of the characteristics and outcome of these patients.
Detailed description
The study aims to compare the outcome of patients with MVPS associated with SSc to patients with MVPS without SSc. This work is a multicenter retrospective study comparing two groups of adult patients, one with MVPS associated with SSc and the other with MVPS without SSc. Patients with MVPS associated with SSc will be recruited from French university hospital departments of Hepatogastroenterology and Internal Medecine. Patients with MVPS without SSc will be recruited from the Beaujon Hospital database dedicated to liver vascular diseases.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| First group : SSC with PSVD | – | –medical file analysis of patients affected by SSC and PSVD |
| Second group : PSVD without SSC | – | –medical file analysis of patients affected by PSVD only |
| Third group : SSC without PSVD | – | –medical file analysis of patients affected by SSC only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 3 types of patients : PSVD with SSC, PSVD without SSC, SSC without PSVD will be compared.
Key inclusion criteria (2 listed)
- PSVD (Valdig criteria)
- SSC (ACR/EULAR 2013 criteria)
Key exclusion criteria (4 listed)
- Liver cirrhosis
- Limited scleroderma
- Autoimmune hepatitis
- Primary biliary cholangitis
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
Prognosis
Time frame: 2 years
To compare prognosis of PSVD patients with or without SSc (less or more gastrointestinal bleeding/portal vein thrombosis)
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 20 Jun 2024.
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 PSVD With or Without SSc, run by University Hospital, Caen at 1 site in France.
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 2 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: finished, as of the sponsor's last update on 20 Jun 2024. 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 France. 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?
Prognosis (time frame: 2 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 20 Jun 2024; AzTrials last refreshed its copy on 26 Oct 2026.