PROSPECT-PLEURA: Biomarker Discovery to Refine Diagnosis and Prognosis in Histologically Indeterminate Pleural Effusions
Diagnosis of patients with exudative pleural effusion
PROSPECT-PLEURA is a single-site, prospective observational diagnostic test accuracy study. There is no randomisation, no control arm, and no intervention; participants receive standard NHS clinical care throughout. Participants Adult NHS patients who are undergoing medically necessary pleural fluid sampling for a suspected or known exudative pleural effusion are eligible for inclusion. Sampling may be via thoracocentesis, intercostal chest drain, or indwelling pleural catheter. Patients with latent, active, or suspected tuberculosis, those requiring emergency pleural drainage, and those who have previously undergone pleurodesis are excluded. Sample Collection Pleural fluid is collected at University Hospitals of Morecambe Bay NHS Foundation Trust during clinically indicated procedures. For therapeutic thoracocentesis, intercostal drain, and IPC, up to 200 mL of surplus fluid is collected. For diagnostic thoracocentesis, up to 50 mL of residual fluid beyond clinical requirements is collected. No additional invasive procedures are undertaken as part of the study. The target sample size is 150 participants, with up to 30 participants donating a second sample, yielding up to 180 samples in total. Sample Processing and Scientific Analysis Samples are transported on the same day to Lancaster University on ice, in compliance with HTA Code E, T1 traceability requirements. At Lancaster University, samples are centrifuged and separated into supernatant and cell pellet. Supernatants are stored at -80°C; cell pellets are fixed or otherwise preserved for analysis. Some unfixed samples are cultured in containment level 2 facilities for short-term experimental use; no in vitro cell lines are established. Scientific analyses include: - Single-cell RNA sequencing of cellular content from pleural fluid, to characterise transcriptional states of immune and mesothelial cells - Multiplex flow cytometry to assess immune and mesothelial cell populations and their expression of ligand
1. Undergoing medically necessary pleural fluid sampling or removal, via any method 2. The pleural effusion is suspected or known to be exudative 2. Aged 18 years or older and has capacity to consent to participate
1. Latent, active, or suspected tuberculosis, whether pulmonary or extra-pulmonary 2. Clinically unstable patients requiring emergency removal of pleural fluid 3. Previous pleurodesis 4. Participating in ongoing PROSPECT-PLEURA patient and public involvement