Meso-ORIGINS: An observational study investigating the origins of mesothelioma

Plain English Summary

Background and study aims
Mesothelioma is an incurable cancer of the lining of the lungs (the pleura), which is strongly associated with previous asbestos exposure. The factors that promote or permit mesothelioma evolution to develop many decades after exposure to asbestos dust are poorly understood, but mesothelioma may be preceded by benign (non-cancerous) inflammation of the pleura in some patients. The diagnosis of asbestos-associated benign pleural inflammation therefore provides a unique window of opportunity study mesothelioma evolution.

We will study samples collected in patients with an initial benign pleural biopsy sample, in whom mesothelioma subsequently develops, and compare these with similar samples from patients that do not evolve in this way. To do this, the study will create a large cohort of matched ‘benign/mesothelioma’ and ‘benign/no mesothelioma’ tissue pairs. This information may help us, and future researchers, design new, more effective treatments for mesothelioma.

Who can participate?
Patients with abnormalities of the pleura who have reported previous asbestos exposure may be eligible. There is no age or gender restriction on participation.

What does the study involve?
This study has 2 arms: Arm A and Arm B, and a MRI sub-study as part of Arm A (site dependent).

Arm A
Arm A will recruit asbestos-exposed participants with an initial benign pleural biopsy result. Participants will be followed up for 2-years following retrieval of their original biopsy for use in the study and collection of a sample of blood and exhaled breath. The breath sample will be collected using a special device that looks like a large inhaler. They will be asked to take deep breaths in and out during this test, which takes around 5 minutes to complete. The study will also request access to any additional scans or biopsies taken over the 2 year follow up. At 18 months participants with no changes may be invited to have another scan and possibly another biopsy as part of the study.

Arm A MRI sub-study
The sub-study will recruit participants at participating sites who have already consented to be part of the study Arm A. Participants who chose to be part of the MRI sub-study will have an MRI performed within 14 days of study enrolment, in addition to the steps noted above.

Arm B
Arm B will recruit asbestos-exposed participants who are going to have biopsies taken because a pleural abnormality has been found by their medical team (e.g. a pleural effusion (a collection of fluid around the lung) or a pleural mass (an area of thickening on the lining of the lung). Participants will have extra biopsy samples taken for study analyses during the biopsy proceure already planned.

What are the possible benefits and risks of participating?
There is unlikely to be any direct benefit to participants taking part, but the results of this study could help us understand how mesothelioma develops and how to effectively diagnose and treat it. This has the potential to greatly improve the lives of patients in the future.
The main disadvantages of the study are related to having a repeat biopsy. The risk involved would be small since the methods by which biopsies are obtained (Local Anaesthetic Thoracoscopy or Image-guided Pleural Biopsy) are safe common procedures and complications from either are rare.
In some cases, the additional biopsy may be done as part of routine care if a participant’s doctor suspects that mesothelioma might be developing. As this would be arranged during normal care, being in the study would not increase any risks related to this.

Where is the study run from?
The study is being coordinated by the University of Glasgow supported by Cancer Research UK Glasgow Clinical Trials Unit (based at the Beatson West of Scotland Cancer Centre in Glasgow) (UK)

When is the study starting and how long is it expected to run for?
August 2021 to August 2027

Who is funding the study?
Cancer Research UK

Who is the main contact?
Professor Kevin Blyth, Kevin.blyth@glasgow.ac.uk
Dr Alexandrea MacPherson, Alexandrea.MacPherson@glasgow.ac.uk

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-to-find-out-more-about-mesothelioma-meso-origin

Study website

Contact information

Dr Alexandrea MacPherson
Public

Institute of Cancer Sciences
University of Glasgow
Garscube Estate
Bearsden
Glasgow
G61 1BD
United Kingdom

Phone	+44 (0)7743822219
Email	alexandrea.macpherson@glasgow.ac.uk

Prof Kevin Blyth
Scientific

Institute of Cancer Sciences
University of Glasgow
Garscube Estate
Bearsden
Glasgow
G61 1QH
United Kingdom

ORCID ID	0000-0003-2972-6641
Phone	+44 (0)7540 534058
Email	kevin.blyth@glasgow.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• Scotland
• United Kingdom
• Wales

Study participating centres

Sponsor information

NHS Greater Glasgow and Clyde
Hospital/treatment centre

Research & Innovation
Ward 11, Dykebar Hospital
Grahamston Road
Paisley
PA2 7DE
Scotland
United Kingdom

Phone	+44 (0)141 314 4001
Email	joanne.mcgarry@ggc.scot.nhs.uk
Website	http://www.nhsggc.org.uk/
"ROR"	https://ror.org/05kdz4d87

Funders

Funder type

Charity

Results and Publications

Editorial Notes

20/11/2024: The contact confirmed the record is up to date.
29/11/2023: Aberdeen Royal Infirmary, Victoria Hospital (blackpool), Ninewells Hospital, Raigmore Hospital, Kettering General Hospital Laboratory, Western General Hospital, Royal Papworth Hospital NHS Foundation Trust, Glenfield General Hospital, Furness General Hospital and The Grange University Hospital study participating centres were added.
15/11/2022: Trial participating centre address details updated.
09/11/2022: Cancer Research UK plain English summary link added to plain English summary field
14/07/2022: The following changes were made to the trial record:
1. The scientific title was changed from "Mesothelioma Observational study of RIsk prediction and Generation of benign-meso tissue pairs, Including a Nested MRI Sub-study" to "Meso-ORIGINS: Mesothelioma Observational study of RIsk prediction and Generation of paired benign-meso tissue samples, Including a Nested MRI Sub-study".
2. The interventions were changed.
3. The target number of participants was changed from 539 to 500.
4. The trial participating centres "Royal Preston Hospital, Royal Stoke University Hospital, Royal Papworth Hospital, Northern General Hospital, Royal Alexandra Hospital" were removed, and "Gartnavel General Hospital, Royal Lancaster Infirmary, Salford Royal" were added.
20/06/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/06/2022 to 16/06/2022.
2. The recruitment end date was changed from 28/02/2025 to 31/08/2025.
3. The overall trial end date was changed from 28/02/2027 to 31/08/2027.
4. Trial website added.
17/05/2022: The recruitment start date was changed from 15/04/2022 to 01/06/2022.
14/03/2022: The recruitment start date was changed from 01/03/2022 to 15/04/2022.
09/12/2021: Ethics approval details added. The recruitment start date was changed from 01/12/2021 to 01/03/2022.
12/10/2021: The recruitment start date was changed from 01/10/2021 to 01/12/2021.
07/09/2021: Internal review.
13/08/2021: Trial's existence confirmed by Cancer Research UK.