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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unprovoked VTE | 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 |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients of 40 years or older with a first episode of objectively confirmed, symptomatic unprovoked distal or proximal deep vein thrombosis or pulmonary embolism.
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| Name | Affiliation | Role |
|---|---|---|
| Harry Büller, MD, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KU Leuven | Leuven | Belgium | ||||
| Ottawa Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26525104 | Background | Best MG, Sol N, Kooi I, Tannous J, Westerman BA, Rustenburg F, Schellen P, Verschueren H, Post E, Koster J, Ylstra B, Ameziane N, Dorsman J, Smit EF, Verheul HM, Noske DP, Reijneveld JC, Nilsson RJA, Tannous BA, Wesseling P, Wurdinger T. RNA-Seq of Tumor-Educated Platelets Enables Blood-Based Pan-Cancer, Multiclass, and Molecular Pathway Cancer Diagnostics. Cancer Cell. 2015 Nov 9;28(5):666-676. doi: 10.1016/j.ccell.2015.09.018. Epub 2015 Oct 29. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D054556 | Venous Thromboembolism |
| D004194 | Disease |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Platelet pellet, EDTA plasma, citrated plasma, and cell-free DNA
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 |
| Ottawa |
| Canada |
| Dresden University Clinic | Dresden | Germany |
| Bologna University Hospital | Bologna | Italy |
| Gabriele D'Annunzio University | Chieti | Italy |
| University of Padua | Padua | Italy |
| University of Insubria | Varese | Italy |
| Academic Medical Center | Amsterdam | North Holland | 1105AZ | Netherlands |
| Flevoziekenhuis | Almere Stad | Netherlands |
| Slotervaartziekenhuis | Amsterdam | Netherlands |
| VU medical center | Amsterdam | Netherlands |
| Tergooiziekenhuizen | Hilversum | Netherlands |
| Leiden University Medical Center | Leiden | Netherlands |
| Hospital Universitario Virgen del Rocio | Seville | Spain |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |