Prospective Study in UPE, version 1.0, 22 May 2012
Research type
Research Study
Full title
Prospective study on the treatment of unsuspected pulmonary embolism in cancer patients.
IRAS ID
144846
Contact name
Suzanne Bleker
Contact email
Sponsor organisation
Academic Medical Centre (AMC)
Duration of Study in the UK
1 years, 1 months, 31 days
Research summary
This is a multicentre, international, prospective study for all ambulatory or hospitalised cancer patients with a first diagnosis of unsuspected pulmonary embolism (PE). Both solid and haematological cancers at any stage of disease will be considered for inclusion.
The scope of this study is to evaluate the current treatment approaches for unsuspected pulmonary embolisms and to assess their efficacy and safety in a large prospective cohort of cancer patients.
The study aims to collect information on signs and symptoms indicative of deep vein thrombosis and pulmonary embolism, possible bleeding events and on the use of anticoagulants and imaging tests.
The study is planned to recruit patients with cancer and unsuspected pulmonary embolism within 3 years. No experimental drug will be used in this study and patients will received the same treatment as patients with a similar disease. During the initial and follow up visits data will be collected on the cancer disease, demographic characteristics, risk factors for venous thromboembolism, concomitant medications and results of diagnositc tests.
Follow up visits are scheduled at 3, 6 and 12 months. Centres will be asked to update information on included patients for a follow up of at least 1 year.
The study does not impose additional visit schedules or examinations outside of routine clinical management and available data will be collected at patients'' visits to their site.
Patients will be excluded in cases of:
1) Age < 18 years;
2) Ongoing anticoagulant therapy for previous venous thromboembolic events or indications for long-term anticoagulation other than deep vein thrombosis or PE;
3) Life expectancy less than 3 months.
The study outcomes are recurrent (symptomatic) venous thromboembolic events including pulmonary embolisms and deep vein thrombosis, bleeding and mortality.Accounting for a drop out rate of about 10%, the final sample of the population would be about 610 patients.
REC name
HSC REC B
REC reference
15/NI/0121
Date of REC Opinion
21 Jul 2015
REC opinion
Further Information Favourable Opinion