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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening tests | Other | This is a one arm study. All patients will receive two screening tests (Doppler ultrasound, upper gastrointestinal endoscopy). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upper gastrointestinal endoscopy and Doppler ultrasound | Procedure | This is a one arm study. All patients will receive two screening tests (Doppler ultrasound, upper gastrointestinal endoscopy). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of asymptomatic portal vein thrombosis (PVT) and/or portal hypertension (PHTN) in patients with Philadelphia negative myeloproliferative neoplasms (MPNs) | 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Identify the patient, disease and treatment related risk factors associated with PVT and PHTN | 6 years | |
| Comparison of survival and number of patients with leukemic transformation in patients with or without asymptomatic PVT/PHTN | 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| Identify any genetic markers or biomarkers associated with asymptomatic PVT and PHTN | 6 years |
Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vikas Gupta, MD, FRCP | The Princess Margaret Cancer Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada | ||
| Princess Margaret Cancer Centre |
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| Toronto |
| Ontario |
| M5G 2M9 |
| Canada |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D011087 | Polycythemia Vera |
| D013920 | Thrombocythemia, Essential |
| D055728 | Primary Myelofibrosis |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D019046 | Bone Marrow Neoplasms |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001778 | Blood Coagulation Disorders |
| D013922 | Thrombocytosis |
| D001791 | Blood Platelet Disorders |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D016145 | Endoscopy, Digestive System |
| ID | Term |
|---|---|
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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