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

Primary Purpose

Myeloproliferative Neoplasms (MPN), Polycythemia Vera (PV), Essential Thrombocythemia (ET)

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Upper gastrointestinal endoscopy and Doppler ultrasound

About this trial

This is an interventional screening trial for Myeloproliferative Neoplasms (MPN)

Eligibility Criteria

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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

Sites / Locations

Sunnybrook Health Sciences Centre
Princess Margaret Cancer Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Screening tests

Arm Description

This is a one arm study. All patients will receive two screening tests (Doppler ultrasound, upper gastrointestinal endoscopy).

Outcomes

Primary Outcome Measures

Incidence of asymptomatic portal vein thrombosis (PVT) and/or portal hypertension (PHTN) in patients with Philadelphia negative myeloproliferative neoplasms (MPNs)

Secondary Outcome Measures

Identify the patient, disease and treatment related risk factors associated with PVT and PHTN

Comparison of survival and number of patients with leukemic transformation in patients with or without asymptomatic PVT/PHTN

Full Information

NCT ID

NCT01816256

First Posted

January 14, 2013

Last Updated

July 19, 2023

Sponsor

University Health Network, Toronto

Collaborators

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01816256

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

May 2013 (undefined)

Primary Completion Date

March 11, 2019 (Actual)

Study Completion Date

March 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Health Network, Toronto

Collaborators

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myeloproliferative Neoplasms (MPN), Polycythemia Vera (PV), Essential Thrombocythemia (ET), Myelofibrosis (MF)

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

102 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Screening tests

Arm Type

Other

Arm Description

This is a one arm study. All patients will receive two screening tests (Doppler ultrasound, upper gastrointestinal endoscopy).

Intervention Type

Procedure

Intervention Name(s)

Upper gastrointestinal endoscopy and Doppler ultrasound

Intervention Description

This is a one arm study. All patients will receive two screening tests (Doppler ultrasound, upper gastrointestinal endoscopy).

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Identify the patient, disease and treatment related risk factors associated with PVT and PHTN

Time Frame

6 years

Title

Comparison of survival and number of patients with leukemic transformation in patients with or without asymptomatic PVT/PHTN

Time Frame

8 years

Other Pre-specified Outcome Measures:

Title

Identify any genetic markers or biomarkers associated with asymptomatic PVT and PHTN

Time Frame

6 years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vikas Gupta, MD, FRCP

Organizational Affiliation

The Princess Margaret Cancer Foundation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sunnybrook Health Sciences Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Princess Margaret Cancer Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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