Clinical trial NCT03965741: Study to Gather Information How Often Venous Thromboembolism Occurs in Prostate Cancer Patients in Sweden and How This Condition is Treated With Blood Thinners
Official title: Prostate Cancer VTE in Sweden: Epidemiology and Anticoagulation Treatment of VTE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism (VTE)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2019-05-29
Enrollment: 97765
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Based on the data from the Prostate Cancer Database Sweden (PCBaSe), containing information from many national registries other than the Cancer register, such as Patient register, Dispensed drug register, Cause of Death registry and Population registries.

Brief summary: Patients with cancer are at a significantly increased risk of experiencing a venous thromboembolism (VTE). VTE is defined by a blood clot in the leg or lower extremity (deep vein thrombosis) or a blood clot in the lung (pulmonary embolism) and is a leading cause of condition of being diseased and death among cancer patients. The goal of the study is to gather information how often venous thromboembolism (VTE) occurs in prostate cancer patients in Sweden and how this condition is treated with blood thinners.


Eligibility criteria: Inclusion Criteria:

* Initially all patients newly diagnosed with PCa between 2007-2016 with at least one year before the end of follow up date (31 December 2017) will be included. From this population, a sub-population of PCa patients with a first cancer-related VTE event will be selected.

Exclusion Criteria:

* None

Primary outcomes:
measure: Subject's socio-demographic at the date of an incident PCa diagnosis
timeFrame: Retrospective analysis between 2007 and 2016
measure: Subject's clinical characteristics at the date of an incident PCa diagnosis
timeFrame: Retrospective analysis between 2007 and 2016
measure: Incidence rate of cancer-related VTE
timeFrame: Retrospective analysis between 2007 and 2016
measure: Cancer therapies in PCa at the initial time after diagnosis
timeFrame: Retrospective analysis between 2007 and 2016
measure: Choice of drug
timeFrame: Retrospective analysis between 2007 and 2016
measure: Duration of treatment
timeFrame: Retrospective analysis between 2007 and 2016
measure: Occurrence of recurrent VTE events
timeFrame: Retrospective analysis between 2007 and 2016
measure: Time between a first cancer-related and a recurrent VTE event
timeFrame: Retrospective analysis between 2007 and 2016
measure: Incidence rates of post-VTE bleeding events leading to hospitalization, and mortality by anticoagulation treatment
timeFrame: Retrospective analysis between 2007 and 2016
Secondary outcomes:
measure: Subject's socio-demographic at the time of inclusion into the database
timeFrame: Retrospective analysis between 2007 and 2016
measure: Subject's clinical characteristics at the time of inclusion into the database
timeFrame: Retrospective analysis between 2007 and 2016
measure: Incidence rate of VTE events
timeFrame: Retrospective analysis between 2007 and 2016
Other outcomes:
Locations:
city: Multiple Locations
country: Sweden
facility: Many Locations
Study officials:
References: