Cancer Clinical Trial - Biomarkers of Thrombosis as Predictors of Venous

Status Recruiting

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04301362
Study type	Observational
Source	Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Contact	Ferreira
Phone	+351933203930
Email	dr.davidferreira@gmail.com
Status	Recruiting
Phase
Start date	July 19, 2019
Completion date	December 19, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Biomarkers of Thrombosis as Predictors of Venous Thromboembolism Risk in Cancer Patients — FIIT_Score

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms