Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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%).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Embolism and Thrombosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Limited cancer screening | Diagnostic Test | — | UNRESOLVED |
| Limited cancer screening + FDG PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Limited cancer screening
- description
- Limited screening alone.
- interventionNames
- Diagnostic Test: Limited cancer screening
- type
- EXPERIMENTAL
- label
- Limited cancer screening + FDG PET/CT
- description
- Limited screening + FDG PET/CT
- interventionNames
- Diagnostic Test: Limited cancer screening + FDG PET/CT
Primary outcomes (1)
- measure
- Occult cancer missed by screening strategies
- timeFrame
- At 1 year of follow-up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: 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: 1. 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 2. recent (less than 3 months) paralysis, paresis or plaster immobilization of the lower extremities; 3. recently bedridden for period of 3 or more days, or major surgery, within the previous 12 weeks requiring general or regional anaesthesia; 4. previous unprovoked VTE; 5. known thrombophilia (hereditary or acquired) Exclusion Criteria: Patients will be excluded from the study if they have any of the following criteria: 1. Refusal or inability to provide informed consent; 2. Hypersensitivity to 18F-FDG or any of the excipients according to the product monograph; 3. Unavailable to follow-up. 4. VTE while on anticoagulation (e.g apixaban, rivaroxaban, edoxaban, dabigatran, warfarin)
References
Publications (3)
- BACKGROUNDRobin P, Le Roux PY, Planquette B, Accassat S, Roy PM, Couturaud F, Ghazzar N, Prevot-Bitot N, Couturier O, Delluc A, Sanchez O, Tardy B, Le Gal G, Salaun PY; MVTEP study group. Limited screening with versus without (18)F-fluorodeoxyglucose PET/CT for occult malignancy in unprovoked venous thromboembolism: an open-label randomised controlled trial. Lancet Oncol. 2016 Feb;17(2):193-199. doi: 10.1016/S1470-2045(15)00480-5. Epub 2015 Dec 8. PMID 26672686
- BACKGROUNDCarrier M, Lazo-Langner A, Shivakumar S, Tagalakis V, Zarychanski R, Solymoss S, Routhier N, Douketis J, Danovitch K, Lee AY, Le Gal G, Wells PS, Corsi DJ, Ramsay T, Coyle D, Chagnon I, Kassam Z, Tao H, Rodger MA; SOME Investigators. Screening for Occult Cancer in Unprovoked Venous Thromboembolism. N Engl J Med. 2015 Aug 20;373(8):697-704. doi: 10.1056/NEJMoa1506623. Epub 2015 Jun 22. PMID 26095467
- BACKGROUNDvan Es N, Le Gal G, Otten HM, Robin P, Piccioli A, Lecumberri R, Jara-Palomares L, Religa P, Rieu V, Rondina M, Beckers MM, Prandoni P, Salaun PY, Di Nisio M, Bossuyt PM, Buller HR, Carrier M. Screening for Occult Cancer in Patients With Unprovoked Venous Thromboembolism: A Systematic Review and Meta-analysis of Individual Patient Data. Ann Intern Med. 2017 Sep 19;167(6):410-417. doi: 10.7326/M17-0868. Epub 2017 Aug 22. PMID 28828492