Platelet RNA profiling to screen for cancer in patients with unprovoked venous thromboembolism
- Conditions
- venous thromboembolismthrombosis1002765510014523
- Registration Number
- NL-OMON47931
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 270
- First, 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
- One or more of the following risk factors for veneuze trombo-embolie (VTE):
- known malignant disease prior to VTE defined as a cancer diagnosis or
cancer treatment within the past 5 years;
- 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 invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>An adjudicated diagnosis of solid or haematological cancer which is confirmed<br /><br>by histology or cytology, or is unequivocally diagnosed by either imaging or<br /><br>tumour markers.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Early-stage solid cancer, defined as stage I or II solid cancer according to<br /><br>the AJCC criteria.<br /><br>- Solid cancer<br /><br>- Hematological cancer<br /><br>- Solid cancer and lymphoma<br /><br>- Recurrent venous thromboembolism<br /><br>- Major bleeding<br /><br>- Clinically relevant non-major bleeding<br /><br>- All-cause mortality<br /><br>- Cancer-related mortality</p><br>