Suspected pleural malignancy or documented history of asbestos exposure Cancer
Conditions
Interventions
Patients with suspected pleural malignancy:
Visit 1 (Day 0, first clinic visit or in patient stay at hospital)
Core Study Activity:
1. Asbestos exposure history
2. Review eligibility criteria
3. Intro
Sponsors
NHS Greater Glasgow and Clyde (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cases of suspected pleural malignancy: 1. Informed written consent 2. Suspected pleural malignancy, as defined by a unilateral pleural effusion or pleural-based mass lesion 3. Sufficient fitness for diagnostic sampling, including diagnostic pleural aspiration as a minimum 4. Aged over 18 Patients with suspected pleural malignancy recruited to the cross-sectional sub-study will be subject to the following additional inclusion criteria: 1. Recruited in a WoS centre (Southern General, Gartnavel General, Glasgow Royal) 2. Thoracoscopy indicated to investigate suspected pleural malignancy (defined by negative pleural cytology and non-specific CT findings) 3. Aged over 18 Asbestos-exposed subjects: 1. Documented history of asbestos exposure and associated pleural plaques, asbestosis or diffuse pleural thickening 2. Informed written consent 3. Willing and able to travel to a research clinic interview in Glasgow 4. Aged over 18
Exclusion criteria
Exclusion criteria: Cases of suspected pleural malignancy: 1. Insufficient fitness (based on the site investigator?s clinical judgement) for diagnostic sampling, including diagnostic pleural aspiration as a minimum Patients with suspected Pleural Malignancy recruited to the cross-sectional sub-study will be subject to the following additional exclusion criteria: 1. Claustrophobia 2. Pregnancy 3. Unable to undergo MR imaging due to known contraindications (e.g. pacemaker, ferrous metal implants or foreign body) 4. Allergy to Gadolinium contrast 5. Renal impairment (eGFR <30ml/min) Asbestos-exposed subjects: 1. Known MPM 2. Known pleural effusion of any cause
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. SOMAscan and Fibulin-3 in blood at presentation 2. Final diagnosis reached | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. SOMAscan and Fibulin-3 levels at presentation and at 3 months 2. Survival Exploratory Research Outcomes 1. Correlation between SOMAscan and/or Fibulin-3 levels and tumour volume, defined by planimetry at contrast-enhanced Magnetic Resonance Imaging 2. Correlation between SOMAscan and/or Fibulin-3 levels and tumour angiogenesis, Redistribution rate constant (Kep) and elimination rate constant (Kel)) on contrast-enhanced magnetic resonance (MR) imaging 3. SOMAscan and Fibulin-3 in paired blood and pleural fluid samples 4. SOMAscan and Fibulin-3 levels at presentation and at 1 month post-biopsy and pleurodesis | — |
Countries
Ireland, United Kingdom
Outcome results
None listed