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

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

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.

Study Overview

• Status: Unknown
• Conditions: Cancer; Thrombosis; Biomarkers; Thromboembolism
• Intervention / Treatment: Diagnostic test: Thrombosis biomarkers

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).

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Study Locations

• Portugal
  • Vila Nova De Gaia, Portugal, 4434-502
    • Recruiting
    • Centro Hospitalar Vila Nova de Gaia/Espinho
    • Contact: David Ferreira, MD; Phone Number: +351933203930; Email: dr.davidferreira@gmail.com
    • Contact: Sara Lopes, MD; Phone Number: +351915281937; Email: sarapblopes@gmail.com
    • Principal Investigator: David Ferreira, MD
    • Principal Investigator: Sara Lopes, MD
    • Principal Investigator: Joana Marinho, MD,PhD
    • Sub-Investigator: Telma Costa, MD
    • Sub-Investigator: Henrique Coelho, MD
    • Sub-Investigator: Ana Barroso, MD
    • Sub-Investigator: Inês Leão, MD
    • Sub-Investigator: Lúcia Vieira, MD
    • Sub-Investigator: Ema Neto, MD
    • Sub-Investigator: Joana Marques, MD
    • Sub-Investigator: Liliana Morais, BSc
    • Sub-Investigator: Isis Alonso, MD
    • Sub-Investigator: Filipa Azevedo, BSc
    • Sub-Investigator: Edgar Mesquita, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cancer patients admitted to Medical Oncology, Clinical Hematology, and Pulmonology consultations at Centro Hospitalar Vila Nova de Gaia/Espinho, Portugal.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	deaths per 100 persons	6 months
Risk factors for the development of VTE	Identify risk factors for the development of VTE in ambulatory cancer patients	6 months
Major Bleeding	major bleeding event	6 months

Collaborators and Investigators

• Sponsor: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
• Collaborators: LEO Pharma; Diagnostica Stago
• Investigators: Principal Investigator: David Ferreira, MD, Centro Hospitalar Vila Nova de Gaia/Espinho

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2019
• Primary Completion (Anticipated): July 19, 2021
• Study Completion (Anticipated): December 19, 2021

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Venous thromboembolism; Thrombin generation; Khorana
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: FIIT_Project

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No applicable

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No