Protocol for a prospective observational cohort study collecting data on demographics, symptoms and biomarkers in people with mesothelioma (ASSESS-meso)

Conway, R. J. H., Symonds, J., Walton, D., Probets, J., Comins, C., Stadon, L., Harvey, J. E., Blyth, K. G. , Maskell, N. A. and Bibby, A. C. (2022) Protocol for a prospective observational cohort study collecting data on demographics, symptoms and biomarkers in people with mesothelioma (ASSESS-meso). BMJ Open, 12(11), e060850. (doi: 10.1136/bmjopen-2022-060850) (PMID:36357003)

Abstract

Introduction: 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. Methods and analysis: 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. Ethics and dissemination: 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. Trial registration number ISRCTN: 61861764.

• Item Type: Articles
• Additional Information: Funding: This study was funded by Avon Mesothelioma Foundation and the PREDICT-Meso Accelerator (funded by Cancer Research UK - Reference C57060/ A29372).
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Blyth, Professor Kevin
• Authors: Conway, R. J. H., Symonds, J., Walton, D., Probets, J., Comins, C., Stadon, L., Harvey, J. E., Blyth, K. G., Maskell, N. A., and Bibby, A. C.
• College/School: College of Medical Veterinary and Life Sciences > School of Cancer Sciences
• Journal Name: BMJ Open
• Publisher: BMJ Publishing Group
• ISSN: 2044-6055
• ISSN (Online): 2044-6055
• Published Online: 10 November 2022
• Copyright Holders: Copyright © Author(s) (or their employer(s)) 2022
• First Published: First published in BMJ Open 12(11):e060850
• Publisher Policy: Reproduced under a Creative Commons license