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

Myeloproliferative Neoplasms Associated SplanChnic Vein Thrombosis: Mascot Registry

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Myeloproliferative Neoplasm; Splanchnic Vein Thrombosis; JAK2 V617
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW3 2QG
    • Royal Free London Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with MPN of any category and splanchnic vein thrombosis

Description

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:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
transformation of MPN	transformation to Myelofibrosis or leukaemia	5 years
progression of liver disease	progression of liver disease	5 years
thrombosis events	new or recurrent or improvement of thrombosis	5 years
haemorrhage events	haemorrhage	5 years

Collaborators and Investigators

• Sponsor: Royal Free Hospital NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): September 1, 2034
• Study Completion (Anticipated): September 1, 2034

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: July 29, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: registry
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Bone Marrow Diseases; Hematologic Diseases; Embolism and Thrombosis; Neoplasms; Thrombosis; Venous Thrombosis; Myeloproliferative Disorders
• Other Study ID Numbers: IRAS 261989

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data of identifiable nature will not be shared. Post analysis data will be published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No