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Discovering new methods of analysing pleural fluid samples to reach a diagnosis earlier in pleural effusions with an unclear cause

PROSPECT-PLEURA: Biomarker Discovery to Refine Diagnosis and Prognosis in Histologically Indeterminate Pleural Effusions

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN15896230
Enrollment
150
Registered
2026-05-21
Start date
2026-07-13
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnosis of patients with exudative pleural effusion Respiratory

Interventions

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 ef
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 conten

Sponsors

Lancaster University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
A final clinical diagnosis, cytology report(s) and biomarker analyses measured using the diagnosis for the formation of a pleural effusion, as determined by the clinical care team. Final diagnosis can be made posthumously. at 3 years

Countries

England, United Kingdom

Contacts

Public ContactOliver Mann
o.mann@lancaster.ac.uk-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 10, 2026