Meso-ORIGINS

Trial Info

Status: Open

Specialty: Lung

Date Opened: 02/08/2022

Planned Close Date: 31/08/2025

Sponsor: NHS Greater Glasgow and Clyde Healthboard

Principal Investigator: Dr Gatheral

Study Title: Meso-ORIGINS: Mesothelioma Observational study of RIsk prediction and Generation of benign-meso tissue pairs, Including a Nested MRI Sub-study

Trial Description

Malignant pleural mesothelioma (MPM) is an incurable cancer of the lining of the lung, which is strongly associated with prior asbestos exposure. MPM typical develops after decades of asbestos-driven benign pleural inflammation and it is not known what triggers the evolution from benign inflammation to MPM, or how best to treat the cancer to reverse or halt these processes.

Meso-ORIGINS forms the prospective tissue collection element of the PREDICT-Meso International Accelerator Network funded by CRUK/AIRC/AECC. Our aim is to generate a large prospective cohort of asbestos-exposed patients with benign initial biopsies that we can retrieve and then match to any subsequent samples acquired at mesothelioma evolution. These samples will be used in downstream pre-clinical work packages to define the biology driving mesothelioma evolution, define new drug targets and validate these in a suite of pre-clinical models generated using the same material. By the end of the 5-year program we aim to have drug-target combinations ready for human trials.

Meso-ORIGINS includes 2 arms, with Arm A recruiting patients with initial benign biopsies and includes baseline collection of blood and breath (+/-MRI depending on site capabilities) for risk profiling - this data will help us design future studies of early intervention in high-risk patients. Arm B will recruit patients with suspected mesothelioma prior to thoracoscopic biopsy), allowing multi-region pleural biopsies for genomic heterogeneity analyses. The latter is particular important in mesothelioma because multiple tumours can exist in different areas of the pleural space and these may evolve at different rates and/or respond in different ways to treatment.

Inclusion Criteria

Arm A Inclusion Criteria

History of asbestos exposure or imaging compatible with this (e.g., pleural plaques)
Any form of pleural biopsy within last 1 year showing evidence of associated pleural inflammation (e.g., benign fibrinous pleurisy, non-specific pleuritis, atypical mesothelial proliferation)
Informed written consent to at least banking of any previous and future pleural tissue samples

Arm A MRI sub-study Inclusion Criteria

Registered to the Arm A
Informed Written Consent to participation in the MRI sub-study

Arm B Arm Inclusion Criteria

Suspected pleural malignancy, as defined by a unilateral pleural effusion mass
History of asbestos exposure or typical radiological features, e.g., pleural plaques
Sufficient fitness for thoracoscopy (LAT or VATS are permissible)
Informed written consent

Exclusion Criteria

Arm A Exclusion Criteria

Any cytologically or histologically confirmed pleural malignancy*
Any pleural infection including TB
Granulomatous pleural inflammation
Any specific pleuritis diagnosed (e.g., Rheumatoid Arthritis)
Previous Pleurodesis

* Clinical suspicion of MPM after an initial negative (benign) pleural biopsy is NOT an exclusion criterion. This includes patients with malignant-looking CT imaging who are NOT excluded.

Arm A MRI sub-study Exclusion Criteria

Any contraindication to MRI, e.g.,claustrophobia, pregnancy, metallic foreign body, pacemaker/implant
Allergy to Gadolinium contrast
eGFR <30 ml/min

Arm B Arm Exclusion Criteria

Current or recent (within last 3 months) intercostal chest drain
Previous Pleurodesis

Contacts

Research Nurse: Kerry Simpson

Administrators: research.randr@mbht.nhs.uk

Link to EDGE

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