Implementing a Tool to Identify Risk for Venous Thromboembolism in Cancer Patients
NCT ID: NCT01602432
Last Updated: 2023-02-27
Study Results
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Basic Information
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WITHDRAWN
OBSERVATIONAL
2012-11-30
2013-08-31
Brief Summary
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Detailed Description
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The best way to treat VTE is its prevention (thromboprophylaxis). Studies suggest that among ambulatory cancer patients, risk for VTE varies markedly between patients and that the lack of knowledge of this risk, delays diagnosis and hampers efforts to effectively prevent VTE. Therefore, the identification of patients at high-risk for VTE may enable faster diagnosis of VTE and better use of thromboprophylaxis.
Recent studies have developed a novel tool to stratify VTE risk in cancer patients before they initiate anti-cancer treatment. We hypothesized that this risk tool will accurately identify cancer patients at high-risk and that its implementation in our clinical practice will result in a faster clinical diagnosis of VTE.
Our objective is: a) to evaluate the ideal strategy to incorporate the tool in our clinical setting as seamlessly as possible, and b) to determine whether the tool accurately predicts risk and results in a faster investigation for VTE.
Patient eligibility will be determined during the patient's initial consult to the Ottawa Cancer Center after cancer diagnosis has been confirmed by the medical Oncologist and before initiation of anticancer treatment. Follow-up for this study will be for 12 months and patients will be seen at the time of scheduled appointments for cancer treatment.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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High Risk Group
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).
No interventions assigned to this group
Low high Risk Group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 who are receiving continuous anticoagulation
18 Years
ALL
No
Sponsors
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The Ottawa Hospital Academic Medical Association
OTHER
Ottawa Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Philip S Wells, MD
Role: PRINCIPAL_INVESTIGATOR
Ottawa Hospital Research Institute
Locations
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Ottawa Hospital Cancer Center
Ottawa, Ontario, Canada
Countries
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References
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Noble 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.
Louzada 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.
Lee 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.
Khorana 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.
Khorana 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.
Khorana 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.
Ay 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.
Carrier M, Tay J, Fergusson D, Wells PS. Thromboprophylaxis for catheter-related thrombosis in patients with cancer: a systematic review of the randomized, controlled trials. J Thromb Haemost. 2007 Dec;5(12):2552-4. doi: 10.1111/j.1538-7836.2007.02751.x. No abstract available.
Stanley A, Young A. Primary prevention of venous thromboembolism in medical and surgical oncology patients. Br J Cancer. 2010 Apr 13;102 Suppl 1(Suppl 1):S10-6. doi: 10.1038/sj.bjc.6605600.
Other Identifiers
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20120209-01H
Identifier Type: -
Identifier Source: org_study_id
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