ONKOTEV-2 trial
Research type
Research Study
Full title
Validation of a risk-assessment score for prediction of venous thromboembolism in cancer outpatients receiving active antitumour treatments: ONKOTEV-2 trial.
IRAS ID
220422
Contact name
Marcia Hall
Contact email
Sponsor organisation
East and North Herts NHS Trust
Duration of Study in the UK
1 years, 8 months, 0 days
Research summary
Blood clots (venous thromboembolism (VTE)) occur more commonly in cancer patients. Ways of evaluating the risk in cancer outpatients represents an emerging area of investigation. There have been various risk-scores that have been developed to try and identify patients at highest risk that may benefit from prophylactic treatment. These risk scores have often included a combination of both clinical and biochemical factors. In the previous ONKOTEV trial the main goal was the introduction to clinical practice of easy-to-use and reproducible tools. This study included 843 patients with different cancer types and several cancer or treatment-related risk factors were investigated. In the analysis several key factors were identified as being able to identify those at highest risk. From this a new risk-assessment model with 4 variables was derived. The goal of ONKOTEV-2 is to confirm that this model works. Eligible patients would be those >18 years with a diagnosis of a solid tumour, who are ambulatory outpatient and are starting a new antitumour treatment which includes chemotherapy, immunotherapy, endocrine therapy or radiation therapy. The study will take approximately 20 months in total with 12 months for enrolment. On inclusion into the study the patients ONKOTEV score will be calculated using routine blood results and clinical information that would be available from their case notes. If the patient was to develop blood clots during the study they would be treated as per local protocol but their ONKOTEV score would be recalculated at this time. The patient will be reassessed via telephone interview at 8 months in order to exclude any current or prior blood clots.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
17/ES/0039
Date of REC Opinion
6 Apr 2017
REC opinion
Further Information Favourable Opinion