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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-19

Study Completion Date

2021-12-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cancer-related Venous Thromboembolic Disease - Cohort Study

NCT06393764

Thrombosis Embolism Thromboses, Venous Cancer

NOT_YET_RECRUITING

US-Doppler and Procoagulant Microparticles for the Diagnosis of Asymptomatic DVT in Advanced Cancer Patients With Poor Performance Status

NCT00336258

Deep Vein Thrombosis Cancer

COMPLETED

Non-Contrast 4DCT to Detect Pulmonary Thromboembolic Events

NCT03183063

Pulmonary Thromboembolisms Pulmonary Embolism

COMPLETED NA

Measure of Plasma Tissue Factor to Predict a Venous Thromboembolism in Primitive Cancer of Lung

NCT02853188

Cancer of Lung

COMPLETED NA

Accuracy of the D-Dimer Assay for the Exclusion of Pulmonary Embolism in a High Risk Oncologic Population

NCT00615147

Cancer Pulmonary Embolism

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Thromboembolism Thrombosis Biomarkers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No