Department of Medicine, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
Academic Respiratory Unit, University of Bristol, Bristol, UK.
BMJ Open. 2022 Nov 10;12(11):e060850. doi: 10.1136/bmjopen-2022-060850.
Mesothelioma is a heterogeneous disease that can be challenging to monitor and prognosticate. ASSESS-meso is a multicentre, prospective, longitudinal observational cohort study of patients with mesothelioma. The primary aim is to describe different clinical phenotypes and investigate predictive and prognostic factors, including biomarkers from blood and pleural fluid. The secondary aim is to provide a resource for future trials and substudies.
We aim to recruit 700 patients with a histological, cytological or clinicopathological diagnosis of mesothelioma, at any anatomical site (pleural, peritoneal, pericardial, etc). Longitudinal data will be collected, including clinical information, radiological investigations, blood tests and patient-reported outcome measures for breathlessness, chest pain and sweats. Preplanned analyses will use Cox proportional hazards method to evaluate factors associated with survival, linear and logistic regression models to investigate associations with symptoms, and analysis of variance modelling to explore changes in symptoms over time.
Ethical approval has been granted by the Research Ethics Committee South West-Central Bristol (17-SW-0019) and Health Research Authority (IRAS ID 220360). A study steering committee has been established and results will be published OpenAccess in peer-reviewed journals.
ISRCTN: 61861764.
间皮瘤是一种异质性疾病，在监测和预后方面具有挑战性。ASSESS-meso 是一项多中心、前瞻性、纵向观察性队列研究，纳入了间皮瘤患者。主要目的是描述不同的临床表型，并研究预测和预后因素，包括来自血液和胸腔积液的生物标志物。次要目的是为未来的试验和子研究提供资源。
我们计划招募 700 名经组织学、细胞学或临床病理学诊断为间皮瘤的患者，这些患者的发病部位为任何解剖部位（胸膜、腹膜、心包等）。将收集纵向数据，包括临床信息、影像学检查、血液检查和患者报告的呼吸困难、胸痛和出汗等症状的结局测量指标。计划的分析将使用 Cox 比例风险方法评估与生存相关的因素、线性和逻辑回归模型来研究与症状的关联，以及方差分析模型来探索症状随时间的变化。
已获得南威尔士-中布里斯托尔研究伦理委员会（17-SW-0019）和英国健康研究管理局（IRAS ID 220360）的伦理批准。已成立一个研究指导委员会，研究结果将在同行评议的期刊上公开获取。
ISRCTN：61861764。
