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

January 14, 2013
May 24, 2013
May 2013
March 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01816256 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Screening for Asymptomatic Portal Vein Thrombosis and Portal Hypertension in Patients With Philadelphia Negative Myeloproliferative Neoplasms
Screening for Asymptomatic Portal Vein Thrombosis and Portal Hypertension in Patients With Philadelphia Negative Myeloproliferative Neoplasms

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
  • Myeloproliferative Neoplasms (MPN)
  • Polycythemia Vera (PV)
  • Essential Thrombocythemia (ET)
  • Myelofibrosis (MF)
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).
Screening tests
This is a one arm study. All patients will receive two screening tests (Doppler ultrasound, upper gastrointestinal endoscopy).
Intervention: Procedure: Upper gastrointestinal endoscopy and Doppler ultrasound
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
March 2015   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Andrea Findlay, BSc, CCRP andrea.findlay@uhn.ca
Canada
 
NCT01816256
MPN 12-01
No
University Health Network, Toronto
University Health Network, Toronto
Novartis Pharmaceuticals
Principal Investigator: Vikas Gupta, MD, FRCP University Health Network - Princess Margaret Cancer Centre
University Health Network, Toronto
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP