Characterization of blood coagulation in cancer patients for the development of an algorithm to predict the risk of thrombosis.
- Conditions
- blood clotthrombosis1002765510014523
- Registration Number
- NL-OMON45551
- Lead Sponsor
- Gelre Ziekenhuizen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 662
Inclusion Criteria
- Cancer (of any type, any stage) diagnosis
- Prior history of VTE (regarding population of 100 patients) or no history of VTE (population of 278 patients)
Exclusion Criteria
- Previously documented coagulation defects
- Prior history of venous thromboembolism (regarding the population of 278 patients)
- Age < 18 years
- Localized squamous or basal cell carcinoma of the skin
- Patient unable to provide informed consent
- Life expectancy < 6 months.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main clinical outcome of the current study is the occurrence of a<br /><br>thrombotic event in the cancer patient cohort. Blood will be collected at<br /><br>baseline patient inclusion and several coagulation tests described below will<br /><br>be performed. The results of these tests will be compared between the group of<br /><br>patients that did and did not suffer from thrombosis, with the aim of<br /><br>discovering potential biomarkers that allow for prediction of thrombosis risk<br /><br>in a cancer patient.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Objectives<br /><br>The secondary objective of this study is to determine the effect of the cancer<br /><br>type and stage and the effect of treatment on the probability to develop<br /><br>thrombosis. Another secondary objective is to assess the effectiveness of<br /><br>anticoagulant therapy in the patients who have suffered from a thrombotic<br /><br>event. In addition, we aim to study the changes in coagulation parameters in a<br /><br>cancer patient at baseline and after a thrombotic event. </p><br>