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

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ClinicalTrials.gov Identifier: NCT01816256
Recruitment Status : Recruiting
First Posted : March 22, 2013
Last Update Posted : October 10, 2018
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

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 or disease Intervention/treatment Phase
Myeloproliferative Neoplasms (MPN) Polycythemia Vera (PV) Essential Thrombocythemia (ET) Myelofibrosis (MF) Procedure: Upper gastrointestinal endoscopy and Doppler ultrasound Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Screening for Asymptomatic Portal Vein Thrombosis and Portal Hypertension in Patients With Philadelphia Negative Myeloproliferative Neoplasms
Study Start Date : May 2013
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019


Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. Incidence of asymptomatic portal vein thrombosis (PVT) and/or portal hypertension (PHTN) in patients with Philadelphia negative myeloproliferative neoplasms (MPNs) [ Time Frame: 6 years ]

Secondary Outcome Measures :
  1. Identify the patient, disease and treatment related risk factors associated with PVT and PHTN [ Time Frame: 6 years ]
  2. Comparison of survival and number of patients with leukemic transformation in patients with or without asymptomatic PVT/PHTN [ Time Frame: 8 years ]

Other Outcome Measures:
  1. Identify any genetic markers or biomarkers associated with asymptomatic PVT and PHTN [ Time Frame: 6 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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 greater than 5 cm 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.
  • Ability to understand and willing to sign a written consent form.
  • Age 18 years or older at time of consent.

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
  • Known history of active bleeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01816256


Contacts
Contact: Rehab Chahin, BHA rehab.chahin@uhn.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Devyani Premkumar       Devyani.Premkumar@sunnybrook.ca   
Principal Investigator: Jeannie Callum         
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

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01816256     History of Changes
Other Study ID Numbers: MPN 12-01
First Posted: March 22, 2013    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018

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