Biomarkers of Thrombosis as Predictors of Venous Thromboembolism Risk in Cancer Patients
- Conditions
- CancerThrombosisThromboembolismBiomarkers
- Registration Number
- NCT04301362
- Lead Sponsor
- Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
- Brief Summary
The main venous thromboembolism (VTE) risk prediction model for ambulatory cancer patients is Khorana. Cancer thrombosis is associated with elevated thrombin generation. Its quantification is a promising method for evaluating patient's thrombotic profile.
This study aims to develop a predictive model of VTE risk in ambulatory cancer patients, combining thrombosis biomarkers (D-dimers and thrombin generation potential) with the Khorana score.
This is a prospective observational study that includes newly diagnosed cancer patients proposed for anti-tumor treatment (chemotherapy, immunotherapy or targeted therapies). Patients with disease progression are allowed if chemotherapy-free for 3 months. A 6-month mean incidence of VTE 6-10% is expected, requiring a sample size of 600 patients. Blood sample is collected at inclusion to analyze thrombosis biomarkers and blood count. The primary endpoint is the occurrence of symptomatic or incidental VTE within 6 months of inclusion. Models will follow a logistic approach with K-fold cross-validation (k=10). Model quality will be assessed with Akaike Information Criterion (AIC) and Bayesian Information Criterion (BIC). Decision for entering predictors in multivariate models will be based on p \<.10 in the univariate analysis.
- Detailed Description
The main aims will be the following:
* Evaluate the utility of the combination of thrombosis biomarkers (D-dimers and thrombin generation potential) with the Khorana score in order to stratify VTE risk in ambulatory cancer patients;
* Determine the potential of this new score in the stratification of cancer patients into high- and low-risk VTE groups, in order to identify patients who would benefit from primary thromboprophylaxis;
* Determine the applicability of the thrombin generation test as an independent factor in the stratification of VTE risk in the cancer population under study;
* Determine the predictive value of D-dimers in the cancer population under study (high versus low risk discrimination).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
- Patients older than 18 years.
- Newly diagnosed cancer patients, proposed for anti-tumor medical treatment (chemotherapy, immunotherapy and targeted therapies).
- Patients with a cancer diagnosis, previously under medical anti-tumor treatments, with disease progression proposed for a new line of anti-tumor treatment, who have not recently received chemotherapy (within the last three months).
- Follow-up in Medical Oncology, Clinical Hematology, and Pulmonology consultations at Centro Hospitalar Vila Nova de Gaia/Espinho.
- Major bleeding in the last 3 months.
- Major surgery in the last 28 days.
- Patients on anticoagulation/antithrombotic therapy
- Pregnant or breastfeeding women.
- Patients previously submitted to bone marrow transplantation.
- Inaccessibility to the results of the biomarkers or other elements provided for in the Khorana score.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of symptomatic or incidental VTE 6 months Confirmed by vascular ultrasound, thoracic angiography, and/or ventilation/perfusion scintigraphy. There will be no routine screening for VTE diagnosis. The symptomatic and incidental episodes documented in the clinical process and complementary diagnostic tests will be considered.
- Secondary Outcome Measures
Name Time Method Mortality 6 months deaths per 100 persons
Risk factors for the development of VTE 6 months Identify risk factors for the development of VTE in ambulatory cancer patients
Major Bleeding 6 months major bleeding event
Trial Locations
- Locations (1)
Centro Hospitalar Vila Nova de Gaia/Espinho
🇵🇹Vila Nova De Gaia, Portugal