Tumor-educated Platelets in Venous Thromboembolism

Study Overview
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Brief Summary
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Among patients with a first episode of unprovoked venous thromboembolism (VTE), the contemporary one-year risk of detecting occult cancer is approximately 4% to 7%. Of these cases, 30% to 60% are missed by routine limited screening for cancer. RNA profiling of platelets is a promising, highly accurate biomarker for cancer detection, but its clinical utility in patients with unprovoked VTE is unknown. The objective of the present study is to evaluate the diagnostic accuracy of platelet RNA profiling in detecting occult cancer in patients with unprovoked venous thromboembolism. Secondary objectives include evaluation of other biomarkers for cancer, prediction of bleeding, and prediction of recurrent VTE.

Official Title
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Platelet RNA Profiling to Detect Occult Cancer in Patients With Unprovoked Venous Thromboembolism

Conditions
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Neoplasms, Venous Thromboembolism

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First episode of objectively confirmed, symptomatic, unprovoked symptomatic pulmonary embolism and/or distal or proximal deep vein thrombosis of the leg Age 40 years or older Written informed consent Exclusion Criteria: known malignant disease prior to VTE defined as a cancer diagnosis or cancer treatment within the past 5 years (of note: suspected but unconfirmed cancer at diagnosis of VTE is allowed); trauma or fracture of the leg, surgical procedures, general anesthesia, or immobilization greater than 3 days within previous 3 months; previous unprovoked venous thromboembolism; known hereditary or acquired thrombophilia; current pregnancy or puerperium (up to 3 months postpartum); current estrogen therapy. Greater than 10 days after VTE diagnosis; Inability for blood withdrawal at baseline; Inability or refusal to provide written informed consent.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Unprovoked VTE<br>Patients aged 40 years or older with a first episode of objectively confirmed, symptomatic, unprovoked deep vein thrombosis of the leg (distal or proximal) or pulmonary embolism | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any solid or hematological cancer | Adjudicated diagnosis of solid or haematological cancer which is confirmed by histology or cytology, or is unequivocally diagnosed by either imaging or tumour markers | Up to one year following venous thromboembolism | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early-stage solid cancer | Early-stage solid cancer, defined as stage I or II solid cancer according to the American Joint Commissee on Cancer criteria. | Up to one year following venous thromboembolism | 
| Recurrent venous thromboembolism | Adjudicated recurrent VTE (see full definition in protocol) | Up to one year following venous thromboembolism | 
| Major bleeding | Adjudicated major bleeding according to the International Society on Thrombosis and Haemostasis criteria | Up to one year following venous thromboembolism | 
| Clinically relevant non-major bleeding | Adjudicated clinically relevant non-major bleeding according to the International Society on Thrombosis and Haemostasis criteria | Up to one year following venous thromboembolism | 
| Composite of major bleeding and clinically relevant non-major bleeding |  | Up to one year following venous thromboembolism | 
| All-cause mortality |  | Up to one year following venous thromboembolism | 
| Cancer-related mortality |  | Up to one year following venous thromboembolism | 
| Solid cancer |  | Up to one year following venous thromboembolism | 
| Hematological cancer |  | Up to one year following venous thromboembolism | 
| Composite of solid cancer and lymphoma |  | Up to one year following venous thromboembolism | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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occult cancer, venous thromboembolism, tumor-educated platelets, platelet RNA profiling, early diagnosis, screening