Department of Hepatobiliary Surgery, Basingstoke and North Hampshire Hospital, Basingstoke, UK.
Perspectum, Oxford, UK
BMJ Open. 2022 Apr 5;12(4):e057163. doi: 10.1136/bmjopen-2021-057163.
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.
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.
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.
NCT04597710.
尽管最近有证据表明定量 MRI 可以改善肝切除术后的结果，但在临床上很少对考虑进行肝切除术的患者进行放射基因组分析。与此同时，全基因组测序报告中越来越多的临床可操作遗传生物标志物的结果尚未完全纳入临床护理路径。
计划进行一项多达 200 名参与者的前瞻性观察队列研究，招募在汉普郡医院 NHS 基金会信托基金考虑进行肝切除术的原发性或继发性肝癌成人。将对数据进行评估，以解决主要终点，计算全基因组测序结果将导致临床管理发生变化的参与者比例。将在手术前为参与者提供额外的非侵入性定量 MRI 扫描，并评估成像结果对治疗决策的影响。
这项研究已由英国国民保健制度健康研究管理局审查，并得到布莱顿和苏塞克斯研究伦理委员会的有利意见（REC 参考：20/PR/0222）。研究结果将与患者和公众参与小组进行讨论，并在相关科学会议上进行报告，并在开放获取期刊上发表。
NCT04597710。
