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Platelet FcGammaRIIa and Risk of Venous Thromboembolism in Cancer

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ClinicalTrials.gov Identifier: NCT05240508
Recruitment Status : Recruiting
First Posted : February 15, 2022
Last Update Posted : April 12, 2022
Information provided by (Responsible Party):
Chris Holmes, University of Vermont

Brief Summary:
Thrombosis is common and contributes significantly to morbidity and mortality in patients with cancer. At least 20% of patients with cancer develop venous thromboembolism (VTE) and another 5% will experience acute arterial thromboembolism (ATE) due to cancer and its treatment. Current guidelines recommend VTE thromboprophylaxis in high-risk outpatients. Thromboprophylaxis strategies are inadequate as 50% of high-risk patients on prophylaxis still develop a VTE, the rate of recurrent VTE is ~24% with a case fatality rate of 14.8%, and the incidence of major bleeding is ~13% with a case fatality rate of 8.9%. We and others have implicated platelets in both the pathogenesis of VTE as well as cancer growth and metastasis. To investigate a new biomarker of risk in patients with cancer, we propose a pilot study to determine whether quantification of platelet FcɣRIIa expression can discriminate risk of VTE and cancer progression. We chose platelet FcɣRIIa expression because we have found that quantifying platelet surface expression of FcγRIIa identifies patients at high and low risk of thrombotic arterial events. Thus, we hypothesize that elevated platelet expression of FcγRIIa will identify patients with cancer who are greater risk of VTE as well as cancer progression. The proposed studies leverage a clinical research program that was established in 2015 at the University of Vermont Cancer Center (Venous Thromboembolism Prevention in the Ambulatory Care Clinic [VTEPACC]) and will allow simultaneous access to research samples, thrombosis complications and cancer outcomes in order to achieve the following specific aims: 1) To determine whether platelet expression of FcγRIIa identifies cancer patients at high and low risk of VTE, and 2) To determine whether increased platelet expression of FcγRIIa is associated with a) advanced stage cancer at the time of enrollment and b) greater progression of cancer. Platelet reactivity is increased in patients with cancer and has been associated with VTE risk. Platelet expression of FcγRIIa can increase the risk of thrombosis by both increasing platelet reactivity and by promoting the procoagulant potential of platelets. In addition, platelets promote cancer by facilitating tumor vascularization, growth, and metastasis. FcγRIIa has been shown to be a key mediator of platelet secretion and cross-talk between platelets and tumor cells. Thus, we propose that increased platelet FcγRIIa expression will be linked to enhanced tumor growth and metastasis by facilitating cancer-tumor cell cross-talk and thereby the activation of platelets that leads to the release of platelet products. Identification of a biomarker capable of discriminating high and low risk of VTE will provide an important precision tool that could be combined with existing tools to guide therapy and improve outcomes. Results from aim 2 will provide key preliminary data in support of novel antiplatelet treatments to limit cancer progression.

Condition or disease
Venous Thromboembolism

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Platelet FcGammaRIIa and Risk of Venous Thromboembolism in Cancer
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Primary Outcome Measures :
  1. venous thromboembolism occurrence [ Time Frame: 18 months ]
    development of VTE or PE

  2. Cancer Progression [ Time Frame: 18 months ]
    Progression and stage of cancer

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a cancer diagnosis who are anticipating starting new outpatient directed chemotherapy/immunotherapy/hormonal or biologic therapy or who will be changing therapy due to disease progression or relapse.

Inclusion Criteria:

  • Active cancer diagnosis receiving cancer directed therapy
  • Willing to consent to participation

Exclusion Criteria:

  • unwilling to provide informed consent,
  • clinical or study physician declines patient enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05240508

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Contact: Chris E Holmes, MD (802) 847-8400 chris.holmes@med.uvm.edu

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United States, Vermont
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05401
Contact: David J Schneider, MD    802-656-8955    david.schneider@uvm.edu   
Contact: Chris Holmes, MD, PhD    802-847-8400    chris.holmes@uvm.edu   
Sponsors and Collaborators
University of Vermont
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Principal Investigator: Chris Holmes, MD PhD University of Vermont
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Responsible Party: Chris Holmes, Professor of Medicine, University of Vermont
ClinicalTrials.gov Identifier: NCT05240508    
Other Study ID Numbers: 1R21CA267074 ( U.S. NIH Grant/Contract )
First Posted: February 15, 2022    Key Record Dates
Last Update Posted: April 12, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chris Holmes, University of Vermont:
Additional relevant MeSH terms:
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Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases