Status:
UNKNOWN
Biomarkers of Thrombosis as Predictors of Venous Thromboembolism Risk in Cancer Patients
Lead Sponsor:
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Collaborating Sponsors:
LEO Pharma
Diagnostica Stago
Conditions:
Cancer
Thromboembolism
Eligibility:
All Genders
18+ years
Brief 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 promis...
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 ri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 19 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 19 2021
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04301362
Start Date
July 19 2019
End Date
December 19 2021
Last Update
March 12 2020
Active Locations (1)
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1
Centro Hospitalar Vila Nova de Gaia/Espinho
Vila Nova de Gaia, Portugal, 4434-502