An observational study of patients with asbestos exposure and pleural disease to assess the feasibility of a future interventional trial where repeat biopsies are taken
| ISRCTN | ISRCTN12840870 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12840870 |
| IRAS number | 253522 |
| Secondary identifying numbers | GN17ON341, IRAS 253522, CPMS 41018 |
- Submission date
- 06/01/2022
- Registration date
- 08/02/2022
- Last edited
- 29/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Mesothelioma is a cancer most commonly affecting the tissue layers which line the lung and inside of the chest wall (the pleura). It most commonly presents with a collection of fluid surrounding the lung (pleural effusion). Mesothelioma is strongly associated with asbestos exposure, which causes intense inflammation of the pleura, but does not occur until many decades after exposure. Benign asbestos pleural effusion (BAPE) is a non-cancerous condition also associated with asbestos exposure and pleural effusion. However, about 12% of patients diagnosed with BAPE are later diagnosed with mesothelioma. It is not currently known what triggers the change from benign pleural inflammation to mesothelioma. The Meso-ORIGINS study aims to define this by performing 2 years of surveillance, collecting measurements from repeat pleural fluid and biopsy (tissue) samples, repeat blood tests and scans. The aim of this study is to determine whether it will be possible to recruit sufficient numbers of patients to Meso-ORIGINS and to work out whether it will possible to perform all of the repeat tests that might be helpful (including biopsies) and whether patients would agree to have these performed.
Who can participate?
Patients of any age with benign asbestos pleural disease
What does the study involve?
Participants will be followed up for 6 months. At 6 months they will have an ultrasound assessment to assess the feasibility of local anaesthetic thoracoscopy and ultrasound-guided biopsy. The participants will also complete a questionnaire to assess their response to various other surveillance strategies. The researchers will also collect data from online databases.
What are the possible benefits and risks of participating?
There are no risks to participants as this is an observational study only. There are no direct benefits to patients but the study results should help inform future management of patients with their condition.
Where is the study run from?
Queen Elizabeth University Hospital, Glasgow (UK)
When is the study starting and how long is it expected to run for?
November 2018 to February 2021
Who is funding the study?
1. June Hancock Mesothelioma Research Fund (UK)
2. Glasgow Clinical Research Facility (UK)
3. Investigator initiated and funded (UK)
Who is the main contact?
Prof. Kevin Blyth
Kevin.blyth@glasgow.ac.uk
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-to-find-out-more-about-mesothelioma-meso-origins
Contact information
Principal Investigator
Institute of Cancer Sciences
University of Glasgow
Garscube Estate
Bearsden
Glasgow
G61 1QH
United Kingdom
| Phone | +44 (0)7540 534058 |
|---|---|
| kevin.blyth@glasgow.ac.uk |
Study information
| Study design | Observational study and retrospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | 40903_PIS_v3.1_01May19.pdf |
| Scientific title | The Meso-ORIGINS feasibility study: an observational study investigating patients with non-malignant asbestos-associated pleural inflammation |
| Study objectives | The current feasibility study will address important areas of uncertainty regarding the current Meso-ORIGINS design, including the technical feasibility and patient acceptability of the proposed surveillance protocol (including repeat local anaesthetic thoracoscopy [LAT]) and the sample size estimate. Alternative strategies for surveillance for transformation to malignant pleural mesothelioma (MPM) will be explored including imaging, blood tests for biomarkers and breath tests. |
| Ethics approval(s) | Approved 30/11/2018, South Central - Hampshire B Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)2071048055; nrescommittee.southcentral-hampshireb@nhs.net), REC ref: 18/SC/0617 |
| Health condition(s) or problem(s) studied | Benign asbestos pleural disease and mesothelioma |
| Intervention | The trial will recruit patients with benign asbestos pleural disease and follow them up for 6 months. At 6 months the patients will have an ultrasound assessment to assess local anaesthetic thoracoscopy and ultrasound-guided biopsy feasibility. The patients will also complete a questionnaire to assess their response to various other surveillance strategies. There is also a retrospective cohort arm to the study which will involve the collection of data from online databases. The following data will be recorded retrospectively for all eligible patients using local anaesthetic thoracoscopy, video-assisted thoracoscopic surgery (VATS) and image-guided biopsy databases and electronic health records at study centres (all data will be recorded in a linked anonymised format): 1. Demographics (age, gender, occupation, asbestos exposure) 2. Baseline clinical data: 2.1. X-ray and CT findings 2.2. Local anaesthetic thoracoscopy findings (date of procedure, views obtained, nature of abnormalities, number of biopsies, lung apposition post-procedure, whether pleurodesis or indwelling pleural catheter performed) 2.3. Histology results 2.4. Blood tests (neutrophils, lymphocytes, platelets, CRP, albumin, LDH, total protein) 2.5. Pleural fluid results (colour, cytology, LDH, albumin, glucose and total protein) 3. Follow-up data (any new pleural or mesothelioma diagnosis since initial biopsy) |
| Intervention type | Mixed |
| Primary outcome measure | Prospective arm: Recruitment rate recorded as the number of eligible participants who consent to participate in the study by 12 months Retrospective arm: Number of eligible patients diagnosed with mesothelioma within 2 years of a diagnosis of BAPE divided by the total number of eligible patients, measured using electronic health records |
| Secondary outcome measures | Prospective arm: Outcomes including hypothetical consent to surveillence strategies (blood tests, breath tests, CT scan, MRI scan, pleural fluid sampling, local anaesthetic thoracoscopy) and reasons if declining consent, assessed using patient questionnaires at study visit 2 (6 months after recruitment, or at study visit 1 if recruited more than 6 months following diagnosis) Retrospective arm: Logistic regression model for mesothelioma transition using patient baseline data from first presentation with pleural disease as predictors |
| Overall study start date | 30/11/2018 |
| Completion date | 15/02/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Observational arm: 27 patients in 12 months |
| Total final enrolment | 39 |
| Key inclusion criteria | 1. History of asbestos exposure or compatible radiology, e.g. pleural plaques 2. Histological diagnosis compatible with benign asbestos pleural effusions (BAPE) including benign fibrinous pleurisy, non-specific pleuritis, atypical mesothelial proliferation Plus for the prospective feasibility study only - histological diagnosis made at LAT 3. Informed written consent 4. Expected prognosis ≥6 months 5. No age range was specified prior to recruitment |
| Key exclusion criteria | 1. Histological diagnosis of MPM or secondary pleural malignancy 2. Pleural infection, empyema or granulomatous pleuritis Plus for the retrospective cohort study only: <2 years follow-up completed at the point of enrolment |
| Date of first enrolment | 01/01/2019 |
| Date of final enrolment | 01/01/2020 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Glasgow
G51 4TF
United Kingdom
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
Old Road
Headington
Oxford
OX3 7LE
United Kingdom
Marlborough Street
Bristol
BS2 8HW
United Kingdom
Sponsor information
Hospital/treatment centre
Dykebar Hospital
Grahamston Road
Paisley
Glasgow
PA2 7DE
Scotland
United Kingdom
| Phone | +44 (0)141 232 7600 |
|---|---|
| joanne.mcgarry@ggc.scot.nhs.uk | |
| Website | https://www.nhsggc.org.uk/locations/hospitals/queen-elizabeth-university-hospital-glasgow/ |
"ROR" |
https://ror.org/05kdz4d87 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- JHMRF
- Location
- United Kingdom
No information available
No information available
Results and Publications
| Intention to publish date | 01/03/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | The study protocol is available on the PREDICT-Meso website (https://www.predictmeso.com). The statistical analysis plan is included in the protocol. The study results will be presented at international respiratory conferences and published in peer-reviewed journals. |
| IPD sharing plan | Study data will be stored in the PREDICT-Meso database in a linked anonymised format. Information regarding data sharing options can be found on the PREDICT-Meso website (https://www.predictmeso.com) or via application to the PREDICT-Meso Project Manager (Alexandrea.Macpherson@glasgow.ac.uk). Consent for use of data in subsequent research was only obtained from patients in the prospective study, therefore only these data can be shared. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3.1 | 01/05/2019 | 04/02/2022 | No | Yes |
| Protocol file | version 1.1 | 10/05/2019 | 04/02/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | prospective observational data | 08/08/2023 | 09/08/2023 | Yes | No |
Additional files
Editorial Notes
29/04/2025: Cancer Research UK link added to plain English summary field.
09/08/2023: Publication reference added.
02/03/2022: Internal review.
04/02/2022: Trial's existence confirmed by South Central - Hampshire B Research Ethics Committee.
