MASCOT-R: MASCOT Registry of Patients With Myeloproliferative Neoplasms Associated Splanchnic Vein Thrombosis

Sponsor
Royal Free Hospital NHS Foundation Trust (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04994158
Collaborator
(none)
600
1
180
3.3

Study Details

Study Description

Brief Summary

A registry of UK patients diagnosed to have splanchnic vein thrombosis and myeloproliferative neoplasm, including isolated mutation of JAK2V617f. The purpose of the registry is to understand outcomes, treatment variations and data to inform and enable future clinical trial design and facilitate regulatory approval decision-making.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Drugs, procedures

Detailed Description

Splanchnic or abdominal vein thrombosis (SVT) comprises thrombosis of hepatic, portal, superior mesenteric, splenic vein in isolation or combination. It has a prevalence of 1-2% in the general population based on autopsy reports. However, 40-50% of patients with hepatic vein thrombosis and about 25-30% of patients with PVT have an underlying myeloproliferative disease that is the cause of the thrombosis. Although some data on MPN-SVT have been published from European registries, the lack of sufficient clinical and scientific data in these patients has led to variation in treatment patterns with regard to timing, choice and duration of anticoagulation, the use of cytotoxic or biologic agents and interventions with thrombolysis and stenting with TIPSS in the acute stage. Data on the patterns of treatment of these patients in U.K and their outcomes with regard to morbidity and mortality are lacking. Availability of such data in U.K. will lead to the design of good quality prospective interventional studies.

PROJECT DESIGN This registry is designed for longitudinal real-world data collection on UK patients with MPN-SVT who are managed at tertiary liver centres in U.K. A pre-defined data set, built by a committee of specialist clinicians from the Mascot registry investigators will be collected and entered into the electronic web-based database built by Dendrite Clinical Systems Ltd.

The data captured includes demographic information linked to the NHS number, which will enable linked-anonymous data accrual and analysis as well as correlation with the Systemic Anti-Cancer Therapy Data Set (SACT) via the National Cancer Registration and Analysis Service (NCRAS) and Cancer Drug Fund (CDF) database. It will also allow interrogation of the national registries for stroke (SSNAP) and cardiac surgery (NACSA) as co-morbidities involving arterial circulation are prevalent in 30% of patients.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
600 participants
Observational Model:
Case-Only
Time Perspective:
Other
Official Title:
Myeloproliferative Neoplasms Associated SplanChnic Vein Thrombosis: Mascot Registry
Actual Study Start Date :
Sep 1, 2019
Anticipated Primary Completion Date :
Sep 1, 2034
Anticipated Study Completion Date :
Sep 1, 2034

Outcome Measures

Primary Outcome Measures

  1. transformation of MPN [5 years]

    transformation to Myelofibrosis or leukaemia

  2. progression of liver disease [5 years]

    progression of liver disease

  3. thrombosis events [5 years]

    new or recurrent or improvement of thrombosis

  4. haemorrhage events [5 years]

    haemorrhage

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age>18 years

  • Myeloproliferative neoplasm (MPN, WHO 2008, WHO 2016, BCSH) and splanchnic vein thrombosis

  • Isolated Jak2v617f allele and splanchnic vein thrombosis

  • MPN and portal cavernoma

Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Royal Free London Hospital London United Kingdom NW3 2QG

Sponsors and Collaborators

  • Royal Free Hospital NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mallika Sekhar, Consultant Haematologist, Royal Free Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT04994158
Other Study ID Numbers:
  • IRAS 261989
First Posted:
Aug 6, 2021
Last Update Posted:
Aug 6, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mallika Sekhar, Consultant Haematologist, Royal Free Hospital NHS Foundation Trust
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 6, 2021