Association between antineoplastic therapies and venous thromboembolism in patients with active cancer

Study type
Protocol
Date of Approval
Study reference ID
17_069
Lay Summary

Blood clots in the veins and lungs (venous thromboembolisms) occur after cancer diagnosis, cancer recurrences and cancer treatment and are particularly common in the following 3-6 months. Blood clots in the veins and lungs are a leading cause of death in cancer patients. The treatments associated with active cancer and blood clots include chemotherapy, radiation, hormones and other treatments. The relationship between the different types of treatment for cancer and the development of blood clots is not well understood. Furthermore, cancer therapies have changed over the last decade with a greater choice of chemotherapy, more targeted radiotherapy, and hormonal/biological therapies cutting off the blood supply to deprive of nutrients the tumour itself. Hence contemporary data is needed on trends over time in the relative contribution of cancer therapies and the change in the association between cancer treatment and the development of blood clots. The purpose of this study is to quantify the association between cancer therapies and the risk of first blood clots in patients with active cancer. This information will help guide clinical research and guide the recognition of patient groups at risk of blood clots following cancer therapy, e.g. for initiation and length of therapies to prevent blood clots.

Technical Summary

This study aims to investigate the association between cancer treatment and the risk of venous thromboembolism (VTE). A cohort of patients with active cancer will be generated and followed for the occurrence of VTE events dependent on the type of cancer therapy. Active cancer will be defined as the 6 month period following either a cancer diagnosis, a cancer therapy, the presence of metastases or a cancer recurrence. Cancer therapy will consist of chemotherapy, cytotoxic drugs, radiation, hormones and immunotherapy. VTE events will include deep vein thromboses and pulmonary embolisms. Adjusted hazard rate ratios of the association between cancer therapy and VTE events will be derived from multivariate Cox regression models including type of cancer therapy as time-dependent variables.

Health Outcomes to be Measured

Venous thromboembolism.

Collaborators

Carlos Martinez - Chief Investigator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Carlos Martinez - Corresponding Applicant - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Alexander Cohen - Collaborator - King's College London (KCL)
Antonio Curcio - Collaborator - University Magna Graecia
Bob Weijs - Collaborator - Maastricht University
Christopher Wallenhorst - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Michela Giustozzi - Collaborator - University of Perugia
Saulius Sudikas - Collaborator - Vilnius City Clinical Hospital
Thalia Field - Collaborator - University Of British Columbia

Linkages

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