Screening for Occult Malignancy in Patients with Unprovoked Venous Thromboembolism
Screening for Occult Malignancy Using 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG PET/CT) in Patients with Unprovoked Venous Thromboembolism
University Hospital, Brest
1,276 participants
Sep 8, 2020
INTERVENTIONAL
Conditions
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 issue for patients who want to know if an underlying cancer might have triggered the VTE. An individual patient-level data meta-analysis (IPDMA) supports extensive screening strategies for occult cancer especially based on FDG PET/CT, and suggests that the best target population for cancer screening would be patients with unprovoked VTE older than 50 years of age (6.7% in patients aged 50 years or more vs. 1.0% in patients of less than 50 years (OR: 7.1, 95% CI: 3.1 to 16%).
Eligibility
Inclusion Criteria7
- 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 Criteria5
- 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)
Interventions
The limited cancer screening will include: 1) a complete medical history and physical examination; 2) complete blood count; 3) liver function tests (AST, ALT, ALP, bilirubin); and 4) chest X-ray. In women, a breast examination, Pap smear/pelvic examination (if \< 70 years old and previously sexually active) and mammogram will be performed, if not conducted in last year. In men, similarly, prostate examination and PSA testing will be performed, if not conducted in the last year. All patients will undergo colon cancer screening as per local practice.
The limited cancer screening (as described above) in combination with a FDG PET/CT.
Locations(20)
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NCT04304651