Study to Gather Information How Often Venous Thromboembolism Occurs in Prostate Cancer Patients in Sweden and How This Condition is Treated With Blood Thinners
PRACTISE
Prostate Cancer VTE in Sweden: Epidemiology and Anticoagulation Treatment of VTE
1 other identifier
observational
97,765
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2019
CompletedFirst Posted
Study publicly available on registry
May 29, 2019
CompletedStudy Start
First participant enrolled
May 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedNovember 30, 2021
November 1, 2021
1.5 years
May 27, 2019
November 24, 2021
Conditions
Outcome Measures
Primary Outcomes (9)
Subject's socio-demographic at the date of an incident PCa diagnosis
Among men with PCa
Retrospective analysis between 2007 and 2016
Subject's clinical characteristics at the date of an incident PCa diagnosis
Among men with PCa
Retrospective analysis between 2007 and 2016
Incidence rate of cancer-related VTE
Among men with PCa
Retrospective analysis between 2007 and 2016
Cancer therapies in PCa at the initial time after diagnosis
Among men with PCa
Retrospective analysis between 2007 and 2016
Choice of drug
Among men with PCa and a first cancer-related VTE event； To characterize the long-term anticoagulation treatment
Retrospective analysis between 2007 and 2016
Duration of treatment
Among men with PCa and a first cancer-related VTE event； To characterize the long-term anticoagulation treatment
Retrospective analysis between 2007 and 2016
Occurrence of recurrent VTE events
Among men with PCa and a first cancer-related VTE event； By long-term anticoagulation treatment (LMWH (Low molecular weight heparin), VKA (Vitamin K anticoagulants) or NOAC (Non-vitamin K oral anticoagulation)) and its estimated duration (up 3 months, 3-6 months, more than 6 months)
Retrospective analysis between 2007 and 2016
Time between a first cancer-related and a recurrent VTE event
Among men with PCa and a first cancer-related VTE event
Retrospective analysis between 2007 and 2016
Incidence rates of post-VTE bleeding events leading to hospitalization, and mortality by anticoagulation treatment
Among men with PCa and a first cancer-related VTE event
Retrospective analysis between 2007 and 2016
Secondary Outcomes (3)
Subject's socio-demographic at the time of inclusion into the database
Retrospective analysis between 2007 and 2016
Subject's clinical characteristics at the time of inclusion into the database
Retrospective analysis between 2007 and 2016
Incidence rate of VTE events
Retrospective analysis between 2007 and 2016
Study Arms (2)
Men with Prostate Cancer (PCa)
Men without PCa
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Janssen Research & Development, LLCcollaborator
Study Sites (1)
Many Locations
Multiple Locations, Sweden
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2019
First Posted
May 29, 2019
Study Start
May 30, 2019
Primary Completion
November 30, 2020
Study Completion
November 30, 2020
Last Updated
November 30, 2021
Record last verified: 2021-11