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

Essential Thrombocythemia (ET) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01816256
• Other study ID #: MPN 12-01
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: March 11, 2019

Study information

• Verified date: July 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 11, 2019
• Est. primary completion date: March 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Essential Thrombocythemia (ET)
• Hypertension, Portal
• Myelofibrosis (MF)
• Myeloproliferative Disorders
• Myeloproliferative Neoplasms (MPN)
• Neoplasms
• Polycythemia
• Polycythemia Vera
• Polycythemia Vera (PV)
• Thrombocythemia, Essential
• Thrombocytosis
• Thrombosis

Intervention

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).

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Novartis Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Identify any genetic markers or biomarkers associated with asymptomatic PVT and PHTN		6 years
Primary	Incidence of asymptomatic portal vein thrombosis (PVT) and/or portal hypertension (PHTN) in patients with Philadelphia negative myeloproliferative neoplasms (MPNs)		6 years
Secondary	Identify the patient, disease and treatment related risk factors associated with PVT and PHTN		6 years
Secondary	Comparison of survival and number of patients with leukemic transformation in patients with or without asymptomatic PVT/PHTN		8 years