Clinical trial · Observational
Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients
- 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)
The same initial and long-term anticoagulation is suggested for unsuspected pulmonary embolism as for patients with symptomatic embolism. Based on these indications, cancer patients with unsuspected pulmonary embolism would be anticoagulated for at least 6 months or until the disease is active, which in most cases would mean indefinite treatment. In fact, dedicated studies on the treatment of unsuspected pulmonary embolism are missing, leaving doubts over the need for (indefinite) anticoagulation which exposes these patients to an increased risk of major bleeding events. Concerns over the need for anticoagulant treatment may especially hold for pulmonary embolism of the distal pulmonary tree since segmental and sub-segmental PE seem to have a more benign course than more proximal embolism. The scope of this study is to evaluate the current treatment approaches for unsuspected pulmonary embolism and to assess their efficacy and safety in a large prospective cohort of cancer patients.
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 |
|---|---|---|---|
| Unsuspected Pulmonary Embolism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Heparin, fondaparinux, vitamin-K antagonists, aspirin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Anticoagulants, aspirin
- description
- Parenteral or oral anticoagulants: heparin, fondaparinux, vitamin-K antagonists, direct thrombin inhibitors, direct factor Xa inhibitors; aspirin. Any dosage, frequency and duration
- interventionNames
- Drug: Heparin, fondaparinux, vitamin-K antagonists, aspirin
Primary outcomes (1)
- measure
- Recurrent (symptomatic) vein thromboembolism, including pulmonary embolism and deep vein thrombosis
- timeFrame
- one year
- description
- Suspected recurrent PE with one of the following: 1. new intra-luminal filling defect on CT scan, MRI scan, or pulmonary angiogram; 2. new perfusion defect of at least 75% on V/Q lung scan; 3. inconclusive spiral CT, pulmonary angiography or lung scan with demonstration of DVT in the lower extremities by CUS or venography Fatal PE is: 1. PE based on objective diagnostic testing or autopsy or 2. death not attributed to a documented cause and for which DVT/PE cannot be ruled out. Suspected (recurrent) DVT with one of the following findings: 1. abnormal CUS; 2. an intra-luminal filling defect on venography.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * cancer patients with a first diagnosis of unsuspected PE Exclusion Criteria: 1. age \<18 years; 2. ongoing anticoagulant therapy for previous VTE or indications for long-term anticoagulation other than deep vein thrombosis (DVT) or PE; 3. life expectancy less than 3 months.
References
Publications (1)
- DERIVEDKraaijpoel N, Bleker SM, Meyer G, Mahe I, Munoz A, Bertoletti L, Bartels-Rutten A, Beyer-Westendorf J, Porreca E, Boulon C, van Es N, Iosub DI, Couturaud F, Biosca M, Lerede T, Lacroix P, Maraveyas A, Aggarwal A, Girard P, Buller HR, Di Nisio M; UPE investigators. Treatment and Long-Term Clinical Outcomes of Incidental Pulmonary Embolism in Patients With Cancer: An International Prospective Cohort Study. J Clin Oncol. 2019 Jul 10;37(20):1713-1720. doi: 10.1200/JCO.18.01977. Epub 2019 May 22. PMID 31116676