Epidemiology of venous thromboembolism in patients with active cancer: a population-based cohort study

Study type
Protocol
Date of Approval
Study reference ID
16_031
Lay Summary

Deep vein thrombosis (DVT) is the formation of a blood clot in a deep vein, usually in a lower limb accompanied with pain and swelling in the affected leg. Left untreated, a DVT can break off and travel in the blood, and may get trapped in the lung and result in a life-threatening pulmonary embolism (PE). The occurrence of malignant disease and its treatment increases the risk of developing a DVT and then PE. Malignancy may be diagnosed prior, during or following the blood clot formation. Blood clots in cancer patients increase the risk of recurrent blood clots and of mortality.
The purpose of the study is to obtain information on the frequency of blood clots and associated mortality in patients with malignancy.
The finding will be important for doctors treating cancer patients as it will help them determine which patients should be considered for preventive therapy to stop blood clots.

Technical Summary

The proposed study aims to estimate the incidence rate of first venous thromboembolism (VTE) in patients with active cancer, and the subsequent risk of recurrent VTE and mortality.
The study will follow a cohort design. One study cohort of patients with active cancer-associated first VTE will be derived from the active-cancer subset of a previously identified cohort of patients with a first VTE. A second cohort with cancer but without VTE will be derived separately.
Descriptive analyses will be conducted to estimate the incidence rates of first VTE in patients with cancer, and the incidence rates of recurrent VTE and all-cause mortality in patients with cancer-associated VTE, presented by cancer type. The cumulative risk of recurrent VTE over time will be derived accounting for mortality as a competing risk.

Health Outcomes to be Measured

Cancer-associated venous thromboembolism All-cause mortality

Collaborators

Carlos Martinez - Chief Investigator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Alexander Cohen - Collaborator - King's College London (KCL)
Anja Katholing - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)

Linkages

HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation