Status:
RECRUITING
Screening for Occult Malignancy in Patients with Unprovoked Venous Thromboembolism
Lead Sponsor:
University Hospital, Brest
Collaborating Sponsors:
Ministry of Health, France
Canadian Institutes of Health Research (CIHR)
Conditions:
Embolism and Thrombosis
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
Venous thromboembolism (VTE) can be the earliest sign of cancer. Identifying occult cancers at the time of VTE diagnosis may lead to significant improvement of patients' care. This is also an upmost i...
Detailed Description
The identification of subgroups of patients at high risk of cancer might enable more efficient screening strategies for early detection of cancer. Venous thromboembolism (VTE) can be the first manifes...
Eligibility Criteria
Inclusion
- Patients aged 50 years or older with a new diagnosis of first unprovoked proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE) will be eligible to participate into the study.
- Unprovoked VTE is defined as the absence of any of the following predisposing factors:
- active malignancy (known malignancy, progressive and/or treated during the last 5 years) except for adequately treated basal or squamous cell carcinoma; Patients whose state of health suggests the presence of cancer at the time of diagnosis of VTE cannot be included in the protocol
- recent (less than 3 months) paralysis, paresis or plaster immobilization of the lower extremities;
- recently bedridden for period of 3 or more days, or major surgery, within the previous 12 weeks requiring general or regional anaesthesia;
- previous unprovoked VTE;
- known thrombophilia (hereditary or acquired)
Exclusion
- Patients will be excluded from the study if they have any of the following criteria:
- Refusal or inability to provide informed consent;
- Hypersensitivity to 18F-FDG or any of the excipients according to the product monograph;
- Unavailable to follow-up.
- VTE while on anticoagulation (e.g apixaban, rivaroxaban, edoxaban, dabigatran, warfarin)
Key Trial Info
Start Date :
September 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 8 2030
Estimated Enrollment :
1276 Patients enrolled
Trial Details
Trial ID
NCT04304651
Start Date
September 8 2020
End Date
September 8 2030
Last Update
December 16 2024
Active Locations (20)
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1
University of Calgary
Calgary, Alberta, Canada
2
University of Manitoba
Winnipeg, Manitoba, Canada
3
McMaster University
Hamilton, Ontario, Canada
4
London Health Sciences Centre
London, Ontario, Canada