Screening for Asymptomatic Portal Vein Thrombosis and Portal Hypertension in Patients With Philadelphia Negative Myeloproliferative Neoplasms

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University Health Network, Toronto
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01816256
First received: January 14, 2013
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

This study involves screening for portal vein thrombosis and portal hypertension in patients with Philadelphia negative myeloproliferative neoplasms (MPNs). These include polycythemia vera (PV), essential thrombocythemia (ET), and myelofibrosis.

Portal vein thrombosis and portal hypertension are serious complications that are often seen in myeloproliferative patients. These complications are usually diagnosed when patients become symptomatic, and are often already at an advanced stage. They can further progress to cause non-reversible damage to the liver, also called cirrhosis of the liver. As a result of this, patients often accumulate fluid in the abdomen which is ascites; and can develop swelling of veins in the lining of the esophagus known as varices. If untreated, varices have the risk of rupturing resulting in life-threatening bleeding. When diagnosed at an advanced stage, the treatment is usually supportive therapy and there are no treatments available at present which can reverse these conditions.

This study is looking at screening for these two conditions using Doppler ultrasound and upper gastrointestinal endoscopy.


Condition Intervention
Myeloproliferative Neoplasms (MPN)
Polycythemia Vera (PV)
Essential Thrombocythemia (ET)
Myelofibrosis (MF)
Procedure: Upper gastrointestinal endoscopy and Doppler ultrasound

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Screening for Asymptomatic Portal Vein Thrombosis and Portal Hypertension in Patients With Philadelphia Negative Myeloproliferative Neoplasms

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Incidence of asymptomatic portal vein thrombosis (PVT) and/or portal hypertension (PHTN) in patients with Philadelphia negative myeloproliferative neoplasms (MPNs) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of baseline characteristics in patients with or without asymptomatic PVT/PHTN [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Comparison of survival and number of patients with leukemic transformation in patients with or without asymptomatic PVT/PHTN [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Screening tests
This is a one arm study. All patients will receive two screening tests (Doppler ultrasound, upper gastrointestinal endoscopy).
Procedure: Upper gastrointestinal endoscopy and Doppler ultrasound
This is a one arm study. All patients will receive two screening tests (Doppler ultrasound, upper gastrointestinal endoscopy).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • One of the three classical Philadelphia negative myeloproliferative neoplasms (polycythemia vera (PV), essential thrombocythemia (ET) and myelofibrosis (MF)) diagnosed according to WHO or International working group-Myelofibrosis research and treatment (IWG-MRT) criteria
  • Palpable spleen length >5 cms below the costal margin in MF (including primary MF or post-polycythemia vera MF (PPV-MF) post-polycythemia vera ET (PPV-ET)) or palpable spleen of any size in patients with PV or ET.

Exclusion criteria:

  • Known history of portal vein thrombosis
  • Known history of Budd-chairi syndrome
  • Known history of oesophageal varices
  • Known history of cirrhosis from any cause
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01816256

Contacts
Contact: Andrea Findlay, BSc, CCRP andrea.findlay@uhn.ca

Locations
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Vikas Gupta, MD, FRCP       vikas.gupta@uhn.ca   
Principal Investigator: Vikas Gupta, MD, FRCP         
Sponsors and Collaborators
University Health Network, Toronto
Novartis Pharmaceuticals
Investigators
Principal Investigator: Vikas Gupta, MD, FRCP University Health Network - Princess Margaret Cancer Centre
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01816256     History of Changes
Other Study ID Numbers: MPN 12-01
Study First Received: January 14, 2013
Last Updated: May 24, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Primary Myelofibrosis
Neoplasms
Hypertension
Polycythemia
Venous Thrombosis
Thrombosis
Hypertension, Portal
Polycythemia Vera
Myeloproliferative Disorders
Thrombocytosis
Thrombocythemia, Essential
Bone Marrow Diseases
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Embolism and Thrombosis
Liver Diseases
Digestive System Diseases
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on September 16, 2014