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

Cancer Clinical Trial

— FIIT_Score  

Official title:

FIIT Project - Biomarkers of Thrombosis as Predictors of Venous Thromboembolism Risk in Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04301362
• Other study ID #: FIIT_Project
• Status: Recruiting
• Start date: July 19, 2019
• Est. completion date: December 19, 2021

Study information

• Verified date: March 2020
• Source: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
• Contact: Ferreira
• Phone: +351933203930
• Email: dr.davidferreira[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 19, 2021
• Est. primary completion date: July 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biomarkers
• Cancer
• Thromboembolism
• Thrombosis
• Venous Thromboembolism

Intervention

Diagnostic Test:
• Thrombosis biomarkers
Blood samples shall be prepared according to the manufacturer's instructions and stored at -80°C until analysis. Thrombin generation will be measured using the commercial kit STG®-Tromboscreen kit (Stago). The D-dimers will be quantified using STA LIATEST® D-DI PLUS (Stago).

Locations

Country	Name	City	State
Portugal	Centro Hospitalar Vila Nova de Gaia/Espinho	Vila Nova De Gaia

Sponsors (3)

Lead Sponsor	Collaborator
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.	Diagnostica Stago, LEO Pharma

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of symptomatic or incidental VTE	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.	6 months
Secondary	Mortality	deaths per 100 persons	6 months
Secondary	Risk factors for the development of VTE	Identify risk factors for the development of VTE in ambulatory cancer patients	6 months
Secondary	Major Bleeding	major bleeding event	6 months