Clinical trial · Observational
Biomarkers of Thrombosis as Predictors of Venous Thromboembolism Risk in Cancer Patients
FIIT Project - Biomarkers of Thrombosis as Predictors of Venous Thromboembolism Risk in Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biomarkers | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Thromboembolism | — | UNRESOLVED | — |
| Thrombosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thrombosis biomarkers | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Occurrence of symptomatic or incidental VTE
- timeFrame
- 6 months
- description
- 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 (3)
- measure
- Mortality
- timeFrame
- 6 months
- description
- deaths per 100 persons
- measure
- Risk factors for the development of VTE
- timeFrame
- 6 months
- description
- Identify risk factors for the development of VTE in ambulatory cancer patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available