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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

Tracking Information
First Submitted Date February 4, 2022
First Posted Date February 15, 2022
Last Update Posted Date April 12, 2022
Actual Study Start Date January 1, 2022
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 4, 2022)
  • venous thromboembolism occurrence [ Time Frame: 18 months ]
    development of VTE or PE
  • Cancer Progression [ Time Frame: 18 months ]
    Progression and stage of cancer
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Platelet FcGammaRIIa and Risk of Venous Thromboembolism in Cancer
Official Title Platelet FcGammaRIIa and Risk of Venous Thromboembolism in Cancer
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
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.
Condition Venous Thromboembolism
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 4, 2022)
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2024
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contact: Chris E Holmes, MD (802) 847-8400 chris.holmes@med.uvm.edu
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT05240508
Other Study ID Numbers 1R21CA267074( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Chris Holmes, University of Vermont
Original Responsible Party Same as current
Current Study Sponsor University of Vermont
Original Study Sponsor Same as current
Collaborators Not Provided
Principal Investigator: Chris Holmes, MD PhD University of Vermont
PRS Account University of Vermont
Verification Date April 2022