Lung adenocarcinoma with malignant pleural effusion Cancer
Conditions
Interventions
Patients to undergo study assessments at baseline, 3 months, and 6 months post enrolment. Each assessment to include: blood and pleural fluid sampling, thoracic ultrasound, chest radiograph, quality o
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Malignant pleural effusion due to lung adenocarcinoma, defined as either: 1.1. An effusion with cytological or histological evidence of lung adenocarcinoma in fluid or pleural tissue; or 1.2. Histologically or cytologically proven lung adenocarcinoma and a pleural effusion with no other demonstrated cause 2. Pleural collection which is either: 2.1. Amenable to safe ultrasound-guided thoracentesis; or 2.2. Treated with a functioning indwelling pleural catheter (IPC)
Exclusion criteria
Exclusion criteria: 1. Age <18 years 2. Patient is not able to provide informed consent to study participation 3. Patient is not willing to attend study follow-up visits 4. Patient has no access to a telephone or other method of remote communication 5. Patient is likely to relocate out of region within 6 months of enrolment 6. Active malignancy other than lung adenocarcinoma 7. Evidence of pleural infection (as determined by the treating clinician) 8. Patient is in the final stages of their life (as determined by the treating clinician) 9. Uncorrectable bleeding diathesis (for patients who would need thoracentesis) 10. Previously enrolled in the OPTICAL study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival at 6 months measured using patient records | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response to individualised anticancer therapy is measured using CT at 3 months and 6 months post enrolment 2. Development of pleurodesis is measured using ultrasound and fluid output at 3 months and 6 months post enrolment 3. Development of pleural fluid septation is measured using ultrasound at 3 months and 6 months post enrolment 4. Radiological tumour progression is measured using CT at 3 months and 6 months post enrolment | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactElisabeth North
Outcome results
None listed