Clinical trial NCT01602432: Implementing a Tool to Identify Risk for Venous Thromboembolism in Cancer Patients
Official title: Implementing a Tool to Identify Risk for Venous Thromboembolism in Cancer Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Venous Thromboembolism
Deep-Vein Thrombosis
Pulmonary Embolism
Cancer
Keywords: Venous Thrombosis
Cancer
Coagulation factors
Blood
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: The Ottawa Hospital Academic Medical Association
First posted: 2012-05-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Because of their higher thrombogenic potential, we will aim to identify high-risk cases for VTE within the group of cancer patients whose primary malignancy is located in the brain, bladder, lung, testicle, pancreas, stomach and lymphomas.

Brief summary: 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.

Detailed description: Patients with Cancer have a risk for venous thromboembolism (VTE) including deep-vein thrombosis (DVT) and/or pulmonary embolism (PE) that is markedly higher than non-Cancer patients. An acute episode of VTE has deleterious effects on the quality of life and long-term survival of cancer patients. Cancer patients with VTE have survival rates that are only one third of otherwise identical patients without VTE. Once VTE is diagnosed over 10% of cancer patients suffer a further event while on standard therapy and over 5% suffer a major hemorrhagic event.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Risk for Venous Thromboembolism
timeFrame: 1 year
Secondary outcomes:
measure: Timing to VTE detection
timeFrame: 1 year
measure: Study Feasibility
timeFrame: 1 year
measure: Physicians acceptance
timeFrame: 1 year
measure: Success of an IS/IT solution
timeFrame: 1 year
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Cancer Center
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Philip S Wells, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.