Implementing a Tool to Identify Risk for Venous Thromboembolism in Cancer Patients

February 23, 2023 updated by: Ottawa Hospital Research Institute
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.

Study Overview

Status

Withdrawn

Conditions

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk for Venous Thromboembolism
Time Frame: 1 year
This outcome will be measured by the cummulative rates of VTE stratified by the different categories of risk as determined by the prediction tool during the time-frame of the study
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timing to VTE detection
Time Frame: 1 year
This will be measured by the time elapsed between the first signs or symptoms associated with a symptomatic VTE as described by the patient and the time of confirming VTE diagnosis.
1 year
Study Feasibility
Time Frame: 1 year
Feasibility will be assessed by: a) achieving an average enrollment rate of at least 39 cancer patients per month; and b) accomplishing a rate of withdrawals or loss to follow-ups equal or less than 10%
1 year
Physicians acceptance
Time Frame: 1 year
This will be assessed by measurements of physician's satisfaction to the implementation of the Risk stratification tool at the end of the study period.
1 year
Success of an IS/IT solution
Time Frame: 1 year
This outcome will be measured by the physician's satisfaction to the implementation of an automatic risk detection.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Collaborators

The Ottawa Hospital Academic Medical Association

Investigators

  • Principal Investigator: Philip S Wells, MD, Ottawa Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

May 16, 2012

First Submitted That Met QC Criteria

May 17, 2012

First Posted (Estimate)

May 21, 2012

Study Record Updates

Last Update Posted (Estimate)

February 27, 2023

Last Update Submitted That Met QC Criteria

February 23, 2023

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120209-01H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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