Tumor-educated Platelets in Venous Thromboembolism
- Conditions
- Venous ThromboembolismNeoplasms
- Registration Number
- NCT02739867
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 476
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Cancer-related mortality 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.
Major bleeding Up to one year following venous thromboembolism Adjudicated major bleeding according to the International Society on Thrombosis and Haemostasis criteria
Recurrent venous thromboembolism Up to one year following venous thromboembolism Adjudicated recurrent VTE (see full definition in protocol)
Composite of major bleeding and clinically relevant non-major bleeding Up to one year following venous thromboembolism Solid cancer Up to one year following venous thromboembolism 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
All-cause mortality 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
Trial Locations
- Locations (14)
Ottawa Hospital
🇨🇦Ottawa, Canada
University of Insubria
🇮🇹Varese, Italy
Dresden University Clinic
🇩🇪Dresden, Germany
University of Padua
🇮🇹Padua, Italy
Tergooiziekenhuizen
🇳🇱Hilversum, Netherlands
Gabriele D'Annunzio University
🇮🇹Chieti, Italy
Flevoziekenhuis
🇳🇱Almere, Netherlands
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
KU Leuven
🇧🇪Leuven, Belgium
Bologna University Hospital
🇮🇹Bologna, Italy
Academic Medical Center
🇳🇱Amsterdam, Noord-Holland, Netherlands
Slotervaartziekenhuis
🇳🇱Amsterdam, Netherlands
VU medical center
🇳🇱Amsterdam, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands