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

Autor:	Conway RJH; Department of Medicine, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK ruairi.conway@doctors.org.uk.; Academic Respiratory Unit, University of Bristol, Bristol, UK., Symonds J; Academic Respiratory Unit, University of Bristol, Bristol, UK.; Department of Respiratory Medicine, North Bristol NHS Trust, Westbury on Trym, UK., Walton D; Academic Respiratory Unit, University of Bristol, Bristol, UK.; Department of Respiratory Medicine, North Bristol NHS Trust, Westbury on Trym, UK., Probets J; Department of Respiratory Medicine, North Bristol NHS Trust, Westbury on Trym, UK., Comins C; Bristol Haematology and Oncology Centre, Bristol Royal Infirmary, Bristol, UK., Stadon L; Department of Respiratory Medicine, North Bristol NHS Trust, Westbury on Trym, UK., Harvey JE; Academic Respiratory Unit, University of Bristol, Bristol, UK.; Department of Respiratory Medicine, North Bristol NHS Trust, Westbury on Trym, UK., Blyth KG; Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.; Beatson Institute, Cancer Research UK Beatson Institute, Glasgow, UK., Maskell NA; Academic Respiratory Unit, University of Bristol, Bristol, UK.; Department of Respiratory Medicine, North Bristol NHS Trust, Westbury on Trym, UK., Bibby AC; Academic Respiratory Unit, University of Bristol, Bristol, UK.; Department of Respiratory Medicine, North Bristol NHS Trust, Westbury on Trym, UK.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2022 Nov 10; Vol. 12 (11), pp. e060850. Date of Electronic Publication: 2022 Nov 10.
DOI:	10.1136/bmjopen-2022-060850
Abstrakt:	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. Competing Interests: Competing interests: ACB has received grants from Fujirebio. JEH is a trustee of the Avon Mesothelioma Foundation. KGB has received grants from Rocket Medical. NAM has received grants from Becton Dickinson & Rocket Medical and is a member of the advisory board for Becton Dickinson. No members of the project team received any financial incentives for their contribution. (© 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.)
Databáze:	MEDLINE
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