Myeloproliferative NeoplasmMascotNCT04631458
Outcomes in Patients With Myeloproliferative Neoplasm and Splanchnic Vein Thrombosis
An observational study of Myeloproliferative Neoplasm and Splanchnic Vein Thrombosis, run by Royal Free Hospital NHS Foundation Trust.
Trial summary
Patients with Myeloproliferative neoplasms are at particular risk for developing arterial and venous thrombosis, especially thrombosis in the splanchnic venous system. The patho-physiology and natural history of MPN related SVT is poorly understood and treatment algorithms vary greatly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasm, Splanchnic Vein Thrombosis, Splanchnic Venous Thrombosis
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 12 Nov 2014to 30 Dec 2021
- 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
- Adult, Older adult
Study population: as above
Who may be able to join
- MPN with SVT between 3 weeks to 5 years of diagnosis of SVT: study arm
- MPN with palpable splenomegaly or enlarged by Ultrasound: control arm
Who cannot join
- Age <18 years Patients with SVT without MPN
About this study
Official title: A Study Assessing Morbidity and Portal Circulation in Patients With Myeloproliferative Neoplasms and Splanchnic Vein Thrombosis
Patients with Myeloproliferative neoplasms are at particular risk for developing arterial and venous thrombosis, especially thrombosis in the splanchnic venous system. The patho-physiology and natural history of MPN related SVT is poorly understood and treatment algorithms vary greatly. This is of considerable importance since the morbidity and mortality in this group of patients is high. This study aims to observe patients with MPN related SVT over a period of five years to document their clinical progress. Methods of observation include clinical assessment, standard investigations and laboratory based research investigations
Read the detailed description
Study Title Morbidity and portal circulation in patients with Myeloproliferative neoplasms and splanchnic vein thrombosis: Mascot Protocol No. MPN-SVT v11; 02/Dec/2013 Study Design Prospective observational longitudinal study of patients with MPN related splanchnic vein thrombosis(study group) and patients with MPN without SVT (control group) Study Participants Patients with myeloproliferative neoplasms (MPN) and splanchnic vein thrombosis (SVT), patients with MPN and splenomegaly.
Number of subjects 40 patients Follow-up duration 5 years Study duration January 2014- January 2019. Primary Objectives 1. To describe morbidity/portal circulation in the patient group over the 18m from baseline 2. To examine if there are changes in endpoints from baseline to 18m 3. To compare patients with MPN related SVT and MPN without SVT Secondary Objectives 1. To describe morbidity/portal circulation in the patient group over 5 years from baseline 2. To examine if there are changes in endpoints from baseline to 5 years 3. To assess the impact of treatment including cytoreductive therapy, Janus kinase (JAK) inhibition and antithrombotic treatment on end points.
- To assess adequacy of anti-thrombotic agents with reference to recurrence, recanalisation and extension of splanchnic thrombosis, non-splanchnic thrombotic events and bleeding frequency.
Exploratory objectives 1. Assess the utility of endothelial colony assay as marker of disease 2. Assess the utility of adhesion molecules as markers of disease
Primary Endpoint Composite end point comprising occurrence or change in morbidity or portal circulation over 18 months Secondary Endpoint Occurence or change in morbidity or portal circulation over 3-5 years
- Conditions
- Myeloproliferative Neoplasm, Splanchnic Vein Thrombosis, Splanchnic Venous Thrombosis, Myeloproliferative Disorders
- Being tested
- standard of care.
- Keywords
- thrombosis, splanchnic, anticoagulation, TIPSS, myeloproliferative
- Medical subject headings
- Myeloproliferative Disorders, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard of care.Other
Observational trial.
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite end point comprising occurrence or change in morbidity or portal circulation over 18 months
analysed by radiologic investigations and clinical progress
Measured: 12-18 months from baseline
Secondary outcomes (1)
1. Occurrence or changes in morbidity over 5 years 2. Occurrence or changes in portal circulation over 5 years
analysed by radiologic investigations and clinical progress
Measured: 5 years from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start12 Nov 2014
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative NeoplasmStudies 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
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Free Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Birmingham
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631458
- Sponsor's protocol ID
- MPN-SVT v11; 02/Dec/2013
- Acronym
- Mascot
- Status last verified
- Sep 2021
- First submitted
- 10 Nov 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- A Study Assessing Morbidity and Portal Circulation in Patients With Myeloproliferative Neoplasms and Splanchnic Vein Thrombosis
- ClinicalTrials.gov ID
- NCT04631458
- Acronym / sponsor ID
- Mascot / MPN-SVT v11; 02/Dec/2013
- Conditions
- Myeloproliferative Neoplasm, Splanchnic Vein Thrombosis, Splanchnic Venous Thrombosis, Myeloproliferative Disorders
- Keywords
- thrombosis, splanchnic, anticoagulation, TIPSS, myeloproliferative
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Royal Free Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University Hospital Birmingham
- Study start
- 12 Nov 2014 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 17 Nov 2020 (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.
Patients with Myeloproliferative neoplasms are at particular risk for developing arterial and venous thrombosis, especially thrombosis in the splanchnic venous system. The patho-physiology and natural history of MPN related SVT is poorly understood and treatment algorithms vary greatly. This is of considerable importance since the morbidity and mortality in this group of patients is high. This study aims to observe patients with MPN related SVT over a period of five years to document their clinical progress. Methods of observation include clinical assessment, standard investigations and laboratory based research investigations
Detailed description
Study Title Morbidity and portal circulation in patients with Myeloproliferative neoplasms and splanchnic vein thrombosis: Mascot Protocol No. MPN-SVT v11; 02/Dec/2013 Study Design Prospective observational longitudinal study of patients with MPN related splanchnic vein thrombosis(study group) and patients with MPN without SVT (control group) Study Participants Patients with myeloproliferative neoplasms (MPN) and splanchnic vein thrombosis (SVT), patients with MPN and splenomegaly.
Number of subjects 40 patients Follow-up duration 5 years Study duration January 2014- January 2019. Primary Objectives 1. To describe morbidity/portal circulation in the patient group over the 18m from baseline 2. To examine if there are changes in endpoints from baseline to 18m 3. To compare patients with MPN related SVT and MPN without SVT Secondary Objectives 1. To describe morbidity/portal circulation in the patient group over 5 years from baseline 2. To examine if there are changes in endpoints from baseline to 5 years 3. To assess the impact of treatment including cytoreductive therapy, Janus kinase (JAK) inhibition and antithrombotic treatment on end points.
- To assess adequacy of anti-thrombotic agents with reference to recurrence, recanalisation and extension of splanchnic thrombosis, non-splanchnic thrombotic events and bleeding frequency.
Exploratory objectives 1. Assess the utility of endothelial colony assay as marker of disease 2. Assess the utility of adhesion molecules as markers of disease
Primary Endpoint Composite end point comprising occurrence or change in morbidity or portal circulation over 18 months Secondary Endpoint Occurence or change in morbidity or portal circulation over 3-5 years
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- as above
Key inclusion criteria (2 listed)
- MPN with SVT between 3 weeks to 5 years of diagnosis of SVT: study arm
- MPN with palpable splenomegaly or enlarged by Ultrasound: control arm
Key exclusion criteria (1 listed)
- Age <18 years Patients with SVT without MPN
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 |
|---|---|---|
| standard of care.Observational trial. | Other | – |
Primary outcome
Composite end point comprising occurrence or change in morbidity or portal circulation over 18 months
Time frame: 12-18 months from baseline
analysed by radiologic investigations and clinical progress
1 secondary outcome
1. Occurrence or changes in morbidity over 5 years 2. Occurrence or changes in portal circulation over 5 years
Time frame: 5 years from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloproliferative Neoplasm and Splanchnic Vein Thrombosis, run by Royal Free Hospital NHS Foundation Trust.
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 1 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 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Composite end point comprising occurrence or change in morbidity or portal circulation over 18 months (time frame: 12-18 months from baseline). 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.