Clinical trial · Observational
Novel Pleural Fluid, Biopsy and Serum Biomarkers for the Investigation of Pleural Effusions
A Prospective Observational Study Examining the Clinical Utility of Novel Pleural Fluid, Biopsy and Serum Bio Markers for the Investigation of Pleural Effusions
NCT03661801CI-TRIAL-00048121INVESTcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to prospectively asses established biomarkers in the diagnosis and prognosis of patients and will include assessment of a number of biomarkers, genomics and proteomics.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Pleural Effusion | — | UNRESOLVED | — |
| Respiratory Disease | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Protein expression levels of specific biomarkers
- timeFrame
- At enrolment
- description
- All study samples will be analysed with specific laboratory based techniques (enzyme-linked immunosorbent assay, ELISA, or luminex assay. \- Existing biomarkers will be prospectively evaluated based on the underlying disease: * Mesothelin * Procalcitonin * Brain natriuretic peptide * Fibulin * Osteopontin * ADA * additional markers will be included on the panel depending on the patient's underlying disease this could include inflammatory markers, cancer related peptides and immune cell profiling. The above tests have been demonstrated in the BTS Guidelines in pleural disease entitled "Investigation of a unilateral pleural effusion in adults" to have utility in the diagnosis of infectious, malignant, tuberculous and heart failure related effusion. Samples will also be processed for the identification of novel markers with diagnostic or therapeutic importance. Specific cell population will be measured with flow cytometry to detect the immune response of different
Secondary outcomes (1)
- measure
- The analysis of protein and gene expression profile in cell subpopulation of pleural fluid, pleural and endobronchial biopsies and blood samples.
- timeFrame
- At enrolment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Undiagnosed pleural effusion or pleural thickening requiring investigation by one of the following: * Pleural aspiration * Pleural biopsies from medical thoracoscopy or * Ultrasound guided biopsies as part of the clinical plan * Suspected lung cancer undergoing bronchoscopy and biopsies. Exclusion Criteria: * Inability to give written informed consent * Inability to obtain pleural fluid, blood, endobronchial or pleural biopsies as applicable
References
Publications (0)
Data not yet available
No reference posted for this study.