Neoplasms, Venous Thromboembolism
Conditions
Keywords
occult cancer, venous thromboembolism, tumor-educated platelets, platelet RNA profiling, early diagnosis, screening
Brief summary
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.
Interventions
None listed
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Any solid or hematological cancer | Up to one year following venous thromboembolism | Adjudicated diagnosis of solid or haematological cancer which is confirmed by histology or cytology, or is unequivocally diagnosed by either imaging or tumour markers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent venous thromboembolism | Up to one year following venous thromboembolism | Adjudicated recurrent VTE (see full definition in protocol) |
| Major bleeding | Up to one year following venous thromboembolism | Adjudicated major bleeding according to the International Society on Thrombosis and Haemostasis criteria |
| Clinically relevant non-major bleeding | Up to one year following venous thromboembolism | Adjudicated clinically relevant non-major bleeding according to the International Society on Thrombosis and Haemostasis criteria |
| Composite of major bleeding and clinically relevant non-major bleeding | Up to one year following venous thromboembolism | — |
| Early-stage solid cancer | Up to one year following venous thromboembolism | Early-stage solid cancer, defined as stage I or II solid cancer according to the American Joint Commissee on Cancer criteria. |
| 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 | — |
| All-cause mortality | Up to one year following venous thromboembolism | — |
Countries
Belgium, Canada, Germany, Italy, Netherlands, Spain
Outcome results
None listed