MASCOT Registry of Patients With Myeloproliferative Neoplasms Associated Splanchnic Vein Thrombosis

Myeloproliferative Neoplasm Clinical Trial

— MASCOT-R  

Official title:

Myeloproliferative Neoplasms Associated SplanChnic Vein Thrombosis: Mascot Registry

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04994158
• Other study ID #: IRAS 261989
• Status: Enrolling by invitation
• Start date: September 1, 2019
• Est. completion date: September 1, 2034

Study information

• Verified date: July 2021
• Source: Royal Free Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 600
• Est. completion date: September 1, 2034
• Est. primary completion date: September 1, 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Myeloproliferative Disorders
• Myeloproliferative Neoplasm
• Neoplasms
• Splanchnic Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Combination Product:
• Drugs, procedures
standard of care only. non interventional registry.

Locations

Country	Name	City	State
United Kingdom	Royal Free London Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Free Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	transformation of MPN	transformation to Myelofibrosis or leukaemia	5 years
Primary	progression of liver disease	progression of liver disease	5 years
Primary	thrombosis events	new or recurrent or improvement of thrombosis	5 years
Primary	haemorrhage events	haemorrhage	5 years