Clinical Trials Logo

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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04994158
Study type Observational [Patient Registry]
Source Royal Free Hospital NHS Foundation Trust
Contact
Status Enrolling by invitation
Phase
Start date September 1, 2019
Completion date September 1, 2034

See also
  Status Clinical Trial Phase
Completed NCT04022785 - PLX51107 and Azacitidine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Phase 1
Not yet recruiting NCT05440838 - Identification of Factors Associated With Treatment Response in Patients With Polycythemia Vera, Essential Thrombocythemia, and Pre-myelofibrosis.
Completed NCT03941769 - 2018-0674 - IL-7 for T-Cell Recovery Post Haplo and CB Transplant - Phase I/II Phase 1/Phase 2
Completed NCT04666025 - SARS-CoV-2 Donor-Recipient Immunity Transfer
Terminated NCT02877082 - Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients Phase 2
Recruiting NCT03589729 - Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Participants With Blood Cancers Phase 2
Completed NCT04605211 - A Distress Reduction Intervention for Patients With BCR-ABL-Negative MPNs or CML on Tyrosine Kinase Inhibitors N/A
Active, not recruiting NCT03588078 - Study of the Safety and Efficacy of APR-246 in Combination With Azacitidine Phase 1/Phase 2
Recruiting NCT05521204 - Olverembatinib for FGFR1-rearranged Neoplasms Phase 2
Completed NCT04192916 - Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms
Not yet recruiting NCT03177928 - Cardiac Changes in Myeloproliferative Neoplasms N/A
Recruiting NCT05419648 - Role of Monocytes Sub-populations in Thrombosis Associated With Myeloproliferative Neoplasms (MonSThr)
Recruiting NCT04955938 - A Study of Fedratinib With IDH Inhibition in Advanced-Phase, IDH-Mutated Ph-Negative Myeloproliferative Neoplasms Phase 1
Recruiting NCT04942080 - Interest of CALR Allele Burden in Diagnosis and Follow-up of Patients With CALR Mutated Myeloproliferative Syndromes (CALRSUIVI) N/A
Completed NCT04146038 - Salsalate, Venetoclax, and Decitabine or Azacitidine for the Treatment of Acute Myeloid Leukemia or Advanced Myelodysplasia/Myeloproliferative Disease Phase 2
Not yet recruiting NCT06468033 - P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk Phase 3
Completed NCT02862366 - Role of the Circulating Procoagulants Microparticles in the Hypercoagulability of MNP Ph1-
Not yet recruiting NCT06022341 - MultiOmic characteriZation of Acute Myeloid Leukemia Evolving From myelopRoliferative Neoplasm to Identify New Targeted Therapeutic Strategies N/A
Recruiting NCT03630991 - Edetate Calcium Disodium or Succimer in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Chemotherapy Phase 1
Not yet recruiting NCT04527666 - Anticoagulation in Gastroesophageal Varices and JAK2 Mutation