DIAPHRAGM: Diagnostic and prognostic biomarkers in the rational assessment of mesothelioma

Not Applicable

Completed

• Conditions: Suspected pleural malignancy or documented history of asbestos exposure; Cancer

• Registration Number: ISRCTN10079972
• Lead Sponsor: HS Greater Glasgow and Clyde (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-17
• Last Update Posted: 20 November 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 709

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified