FIIT Project - Biomarkers of Thrombosis as Predictors of Venous Thromboembolism Risk in Cancer Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Occurrence of symptomatic or incidental VTE
- Last Updated
- 6 years ago
Overview
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).
Investigators
Dr. David Ferreira
MD Immunohemotherapy Department
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Occurrence of symptomatic or incidental VTE
Time Frame: 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 Outcomes
- Mortality(6 months)
- Risk factors for the development of VTE(6 months)
- Major Bleeding(6 months)