Tumor-educated Platelets in Venous Thromboembolism

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)476 enrolled

Overview

Among patients with a first episode of unprovoked venous thromboembolism (VTE), the contemporary one-year risk of detecting occult cancer is approximately 4% to 7%. Of these cases, 30% to 60% are missed by routine limited screening for cancer. RNA profiling of platelets is a promising, highly accurate biomarker for cancer detection, but its clinical utility in patients with unprovoked VTE is unknown. The objective of the present study is to evaluate the diagnostic accuracy of platelet RNA profiling in detecting occult cancer in patients with unprovoked venous thromboembolism. Secondary objectives include evaluation of other biomarkers for cancer, prediction of bleeding, and prediction of recurrent VTE.

Study Type

OBSERVATIONAL

Enrollment

476

Conditions

Neoplasms Venous Thromboembolism

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * First episode of objectively confirmed, symptomatic, unprovoked symptomatic pulmonary embolism and/or distal or proximal deep vein thrombosis of the leg * Age 40 years or older * Written informed consent Exclusion Criteria: * known malignant disease prior to VTE defined as a cancer diagnosis or cancer treatment within the past 5 years (of note: suspected but unconfirmed cancer at diagnosis of VTE is allowed); * trauma or fracture of the leg, surgical procedures, general anesthesia, or immobilization greater than 3 days within previous 3 months; * previous unprovoked venous thromboembolism; * known hereditary or acquired thrombophilia; * current pregnancy or puerperium (up to 3 months postpartum); * current estrogen therapy. * Greater than 10 days after VTE diagnosis; * Inability for blood withdrawal at baseline; * Inability or refusal to provide written informed consent.

Locations (14)

KU Leuven

Leuven, Belgium

Ottawa Hospital

Ottawa, Canada

Dresden University Clinic

Dresden, Germany

Bologna University Hospital

Bologna, Italy

Gabriele D'Annunzio University

Chieti, Italy

University of Padua

Padua, Italy

University of Insubria

Varese, Italy

Academic Medical Center

Amsterdam, North Holland, Netherlands

Flevoziekenhuis

Almere Stad, Netherlands

Slotervaartziekenhuis

Amsterdam, Netherlands

...and 4 more locations

Outcomes

Primary Outcomes

Any solid or hematological cancer

Adjudicated diagnosis of solid or haematological cancer which is confirmed by histology or cytology, or is unequivocally diagnosed by either imaging or tumour markers