1507TiP - Validation of a risk-assessment score for prediction of venous thromboembolism in cancer outpatients receiving active treatments: ONKOTEV-2 trial

Abstract

Venous thromboembolism (VTE) risk assessment is an outstanding area of investigation. In a previous large prospective study, involving more than 800 ambulatory cancer patients from two European academic institutions, we pioneered an extensive screening with a upper and lower limbs ultrasound to all patients to have the most precise incidence of VTE in cancer outpatients (ONKOTEV trial - data under submission). We investigated several risk factors potentially associated to a increased risk of thrombosis and tested the efficacy of Khorana score in preventing VTE events. We finally constructed a four-cathegory risk model score, improving the predictability of VTE in cancer outpatients. The four variables included in the ONKOTEV score are the following: the presence of metastases, a positive history of previous VTE, the macroscopic compression of vessels or lymphnodes by tumor mass and a Khorana score point of 2 or more. The validation of this new risk assessment model is the goal of the further prospective trial, ONKOTEV 2. Trial design: ONKOTEV 2 trial is an observational, multicentric, no-profit study, endorsed by EORTC Young Investigator Program, and aims to validate the ONKOTEV score as novel easy-to-use tool for the prediction of VTE in ambulatory cancer patients starting a new antitumoral treatment (chemotherapy, endocrine therapy, radiation therapy or surgery). The study will be based on clinical, laboratory and imaging data collection, which will allow to calculate the ONKOTEV score in each patient at baseline. The patient will be clinically monitored for 8 months, in order to detect any thromboembolic event during the trial. The duration of the study will be approximately 20 months. It will be a first analysis at the time of the visit inclusion (T0), a control visit at 8 months (T8). The median period of observation will be 8 months. It is expeted to enroll 465 patients. Legal entity responsible for the study: Study coordination: European Institute of Oncology