NCT05240508

Platelet FcGammaRIIa and Risk of Venous Thromboembolism in Cancer

Status unknown Last updated 17 May 2023

What this trial tests

trial in Venous Thromboembolism in 600 participants. Status unknown.

Timeline

1 January 2022

Primary endpoint
31 December 2024

31 December 2024

Quick facts

Lead sponsor	University of Vermont
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	600
Start date	1 January 2022
Primary completion	31 December 2024
Estimated completion	31 December 2024
Sites	1 location across United States

Conditions studied

• Venous Thromboembolism — all drugs for Venous Thromboembolism →

Sponsor

University of Vermont

Who can join

18 and older, any sex, with Venous Thromboembolism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent Advances on the Molecular Mechanism and Clinical Trials of Venous Thromboembolism.
   Huang SL, Xin HY, Wang XY, Feng GG, et al · · 2023 · cited 11× · PMID 38111686 · DOI 10.2147/jir.s439205
2. Platelet FcɣRIIa: a novel biomarker of risk for thromboembolism and death in cancer.
   Holmes CE, Davis GA, Taatjes-Sommer HS, Sai-Hardebeck NE, et al · · 2026 · PMID 42149304 · DOI 10.1007/s11239-026-03315-2