Clinical trial · Observational
Implementing a Tool to Identify Risk for Venous Thromboembolism in Cancer Patients
NCT01602432CI-TRIAL-00064248withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Project did not meet criteria of a research study and was confirmed as a Quality Initiative Project
Summary
Brief summary (as posted)
Cancer increases the risk of deep vein blood clots and clots traveling to the lungs (emboli) which cause morbidity (leg swelling, pain, and shortness of breath), sudden death, delays cancer treatment, and decreases cancer survival by 66% compared to similar cancer patients without blood clots. Blood thinners may prevent clots but major bleeding is also a problem, so preventive therapies are not used routinely. Identifying patients at highest risk for clots is critical. A tool exists but it has not been used outside of research. We propose to study how to apply this tool in clinical practice and test if it works.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Deep-Vein Thrombosis | — | UNRESOLVED | — |
| Pulmonary Embolism | — | UNRESOLVED | — |
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- High Risk Group
- description
- Defined as patients whose primary malignancy is located in the brain, bladder, lung, testicle, stomach, pancreas and lymphatic system and whose risk score before the beginning of anticancer treatment is ≥ 2 according to the Risk Stratification Method proposed by Khorana et al. (2008). Based on this method, the model includes 5 predictive variables as follows: 1. Site of cancer: classified as very high-risk (+2 points) or high-risk (+1 point). 2. Platelet count: (\>350 x 109/L) (+1 point) 3. Hemoglobin level (\<100 g/L) and/or use of erythropoiesis stimulating agents (+1 point) 4. Leukocyte count (\> 11 x 109/L)(+1 point). 5. body mass index (≥ 35 Kg/m2) (+1 point).
- label
- Low high Risk Group
- description
- Defined as patients whose primary malignancy is located in the brain, bladder, lung, testicle, stomach, pancreas and lymphatic system and whose risk score before the beginning of anticancer treatment is \< 2 according to the Risk Stratification Method proposed by Khorana et al. (2008). In order to confirm the patient low risk status, we will draw a blood sample to determine serum levels of D- dimer and soluble P selectin in patients of this low risk group according to Ay et al. (2010). If levels of D-dimer are ≥ 1.44 µg/mL and/or soluble P selectin ≥ 53.1 ng/mL, we will add one point for each one of the increased biochemical marker and the total score recalculated.
Primary outcomes (1)
- measure
- Risk for Venous Thromboembolism
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years old or older * with a newly diagnosed cancer site (brain, bladder, lung, testicle, pancreas, stomach and lymphomas) * or progression of the malignant disease after complete or partial remission who have not recently received chemotherapy (≤ 3 months), radiotherapy and surgery (≤ 2 weeks) Exclusion Criteria: * Cancer patients with confirmed VTE or arterial embolism within the last 3 months * Cancer patients who are receiving continuous anticoagulation
References
Publications (9)
- BACKGROUNDNoble S, Pasi J. Epidemiology and pathophysiology of cancer-associated thrombosis. Br J Cancer. 2010 Apr 13;102 Suppl 1(Suppl 1):S2-9. doi: 10.1038/sj.bjc.6605599. PMID 20386546
- BACKGROUNDLouzada ML, Majeed H, Dao V, Wells PS. Risk of recurrent venous thromboembolism according to malignancy characteristics in patients with cancer-associated thrombosis: a systematic review of observational and intervention studies. Blood Coagul Fibrinolysis. 2011 Mar;22(2):86-91. doi: 10.1097/MBC.0b013e328341f030. PMID 21245746
- BACKGROUNDLee AY, Levine MN, Baker RI, Bowden C, Kakkar AK, Prins M, Rickles FR, Julian JA, Haley S, Kovacs MJ, Gent M; Randomized Comparison of Low-Molecular-Weight Heparin versus Oral Anticoagulant Therapy for the Prevention of Recurrent Venous Thromboembolism in Patients with Cancer (CLOT) Investigators. Low-molecular-weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. N Engl J Med. 2003 Jul 10;349(2):146-53. doi: 10.1056/NEJMoa025313. PMID 12853587
- BACKGROUNDKhorana AA, Francis CW, Culakova E, Fisher RI, Kuderer NM, Lyman GH. Thromboembolism in hospitalized neutropenic cancer patients. J Clin Oncol. 2006 Jan 20;24(3):484-90. doi: 10.1200/JCO.2005.03.8877. PMID 16421425
- BACKGROUNDKhorana AA, Connolly GC. Assessing risk of venous thromboembolism in the patient with cancer. J Clin Oncol. 2009 Oct 10;27(29):4839-47. doi: 10.1200/JCO.2009.22.3271. Epub 2009 Aug 31. PMID 19720906
- BACKGROUNDKhorana AA, Kuderer NM, Culakova E, Lyman GH, Francis CW. Development and validation of a predictive model for chemotherapy-associated thrombosis. Blood. 2008 May 15;111(10):4902-7. doi: 10.1182/blood-2007-10-116327. Epub 2008 Jan 23. PMID 18216292
- BACKGROUNDAy C, Dunkler D, Marosi C, Chiriac AL, Vormittag R, Simanek R, Quehenberger P, Zielinski C, Pabinger I. Prediction of venous thromboembolism in cancer patients. Blood. 2010 Dec 9;116(24):5377-82. doi: 10.1182/blood-2010-02-270116. Epub 2010 Sep 9.