Risk factors for venous thromboembolism and serious bleeding events in patients with active breast, prostate, ovary, colorectal and lung cancer

Study type
Protocol
Date of Approval
Study reference ID
17_236
Lay Summary

Patients with newly diagnosed cancer and those receiving cancer therapy have a high risk of developing blood clots in a deep vein or lungs. When part or all of that clot breaks off and travels to the lungs it can be life threatening. Blood thinners may decrease the risk of clots but also increase the risk of bleeding. Both blood clots and bleeding need medical attention, may require hospitalisation and have a higher risk of death. The aim of the current project is to identify risk factors for blood clots and of bleeding in patients with active breast, prostate, ovary, bowel and lung cancer. Knowledge about each individual's risk of clots and bleeding could help clinicians to assess which individuals might benefit from therapy with blood thinners.

Technical Summary

This study aims to determine predictors for the risk of venous thromboembolism (VTE) and separately for serious bleeding events in patients with one of the following five active cancer types: breast, prostate, ovary, colorectal and lung cancer. Active cancer will be defined as the 6 month period following a first cancer diagnosis, a subsequent diagnosis of cancer progression or cancer-specific therapy. The active cancer cohort will be stratified by the 5 cancer types and followed separately for the first occurrence of a clinical outcome of interest, either a VTE event or a serious bleeding event. Exposures of interest for each study outcome and for each cancer type are cancer-specific information (e.g. histology, stage and tumour size) and cancer-specific therapy (i.e. chemotherapy, cytotoxic drugs, radiotherapy, hormonal therapy and immunotherapy). Adjusted hazard rate ratios of the association between the exposures of interest and the clinical outcomes will be derived for each outcome and for each cancer type from multivariate Cox regression models. Estimates will be adjusted for co-morbidities, co-medications, patient demographics and lifestyle factors.

Health Outcomes to be Measured

Venous thromboembolism; Serious bleeding.

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)
Anja Katholing - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Christopher Wallenhorst - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Laura Franco - Collaborator - University of Perugia
Marjolein Brekelmans - Collaborator - University of Amsterdam
Savino Sciascia - Collaborator - University of Torino

Linkages

HES Admitted Patient Care;NCRAS Cancer Registration Data;NCRAS Systemic Anti-Cancer Treatment (SACT) data;ONS Death Registration Data;Patient Level Index of Multiple Deprivation