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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

The Meso-ORIGINS feasibility study: an observational study investigating patients with non-malignant asbestos-associated pleural inflammation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN12840870
Enrollment
27
Registered
2022-02-08
Start date
2019-01-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign asbestos pleural disease and mesothelioma Cancer Mesothelioma

Interventions

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 thoracosco

Sponsors

NHS Greater Glasgow and Clyde
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

England, Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 8, 2026