Precision medicine for liver tumours with quantitative MRI and whole genome sequencing (Precision1 trial): study protocol for observational cohort study

Abstract

Introduction: Radiogenomic analysis of patients being considered for liver resection is seldom performed in the clinic despite recent evidence indicating that quantitative MRI could improve posthepatectomy outcomes. Meanwhile, the increasingly accessible results from whole genome sequencing reporting on clinically actionable genetic biomarkers are yet to be fully integrated into the clinical care pathway.

Methods and analysis: A prospective observational cohort study of up to 200 participants is planned, recruiting adults with primary or secondary liver cancer being considered for liver resection at Hampshire Hospitals NHS Foundation Trust. The data will be evaluated to address the primary endpoint to calculate the proportion of participants in which the results from whole genome sequencing would have resulted in a change in clinical management. Participants will be offered an additional non-invasive quantitative MRI scan prior to the operation and the impact of the imaging results on treatment decision-making will be evaluated.

Ethics and dissemination: This study was reviewed by the NHS Health Research Authority and given favourable opinion by the Brighton and Sussex Research Ethics Committee (REC reference: 20/PR/0222). Research findings will be discussed with a patient and public involvement and engagement group, presented at relevant scientific conferences and published in open access journals.

Trial registration number: NCT04597710.

Keywords: genetics; hepatobiliary surgery; magnetic resonance imaging.

Conflict of interest statement

Competing interests: JJC, MK and RB work at and are shareholders of Perspectum.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1

Study flow chart. Participants with informed consent will undergo pretreatment measurements at study visit 1 including height and weight, blood pressure, an online questionnaire, a non-contrast MRI scan and standard liver blood tests. Standard-of-care treatment will be followed and a blood sample and a sample tumour tissue explant will be collected. Twelve months following recruitment, a post-treatment telephone interview will occur as study visit 2. BMI, body mass index.