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

Our plain-English summary of Protocol for a prospective observational cohort study collecting data on demographics, symptoms and biomarkers in people with mesothelioma (ASSESS-meso), by R.J.H. Conway, J. Symonds, D. Walton, et al (BMJ Open, 2022).

The study

• Authors: R.J.H. Conway, J. Symonds, D. Walton, J. Probets, C. Comins, L. Stadon, J.E. Harvey, K.G. Blyth, N.A. Maskell, A.C. Bibby
• Journal: BMJ Open
• Published: 2022;12(11):e060850
• Cited by: 6 articles, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

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.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

In plain English

This article was a study protocol describing a planned study; it reported no results. ASSESS-meso was designed as a multicentre, prospective, longitudinal observational cohort study of people with mesothelioma in the UK. The authors aimed to recruit 700 adults with mesothelioma at any anatomical site at up to 20 hospitals. Recruitment started on 4 July 2017, and 15 hospitals had opened the study when the protocol was written. At visits at least every three months, the team planned to record clinical details and treatments. Planned measures included questionnaires on quality of life, breathlessness, chest pain, sweats, anxiety and depression, and blood tests including mesothelin. Pleural fluid would be tested if appropriate, follow-up imaging done when clinically indicated, and samples stored only with additional consent. The primary aim was to describe different clinical patterns of the disease and look for factors associated with survival and treatment response. A secondary aim was to provide a resource for future trials. The authors expected the study to provide insight into different disease pathways and outcomes. They stated that its main limitation is that it is observational, so analysis will be mainly descriptive.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Study protocol for a multicentre, prospective, longitudinal observational cohort study (no results reported)
• Who was studied: Planned recruitment of 700 adult patients (age 18 or over) with mesothelioma at any anatomical site, at up to 20 UK hospitals; recruitment began 4 July 2017 and the study was open at 15 hospitals at the time of writing
• The authors' conclusion: The authors expected that describing the variety of clinical phenotypes would provide insight into different disease pathways and outcomes, and that stored samples would support research on blood and pleural biomarkers
• Limitations the authors state:
  • The authors stated the main limitation is that the study is observational, so analysis will be primarily descriptive, with scope for regression analysis and hazards modelling

Topics

The National Library of Medicine indexes this study under subjects our site covers: Lung cancer, Mesothelioma.

Medical terms in this study, explained in our Lexicon: Cohort Study, Biomarker, Mesothelioma, Pericardial.

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