Mesothelioma (cancer of the outer lining of the lung) Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histological, cytological or clinico-pathological diagnosis of mesothelioma, confirmed at MDT 2. Willing and able to comply with study follow up assessments (including at least 1 appointment at a study recruiting centre if identified at a PIC) 3. Has capacity, as defined by the 2005 Mental Capacity Act
Exclusion criteria
Exclusion criteria: 1. Age < 18 years old 2. Unable to give written informed consent 3. Declines ongoing hospital follow up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival is measured as time from diagnosis to death (or censored at the point of withdrawal from the study) at every study visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Disease progression, assessed on CT scans using modified RECIST criteria at baseline and every 6 months 2. Change in serum mesothelin from baseline, assessed on blood tests taken at baseline and every 3 months 3. Patient reported symptom scores for breathlessness, chest pain and sweats, measured using visual analogue scales at baseline and every 3 months. 4. Patient reported quality of life, assessed using the EQ-5D-5L questionnaire, at baseline and every 3 months. 5. Pleurodesis rates assessed using pleural catheter drainage diaries, chest x-ray and thoracic ultrasound every 3 months. Pleurodesis is defined as "less than 50ml of pleural fluid drained on 3 or more successive drainages, with no evidence of residual fluid on chest x-ray or ultrasound". 6. Health services utilisation, assessed from patient history and hospital records every 3 months. In addition data will be collected on confounding factors including: 1. Patient characteristics e.g. age, sex, presence of comorbidities, performance status - collected at baseline from patient history & medical records 2. Tumour variables e.g. histological type, disease site - collected at baseline from medical records 3. Treatment factors e.g. chemotherapy, radiotherapy, participation in clinical trials - collected at baseline and every 3 months based on patient history 7 medical records | — |
Countries
England, Scotland, United Kingdom, Wales