Novel Pleural Fluid, Biopsy and Serum Biomarkers for the Investigation of Pleural Effusions (INVEST)
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|ClinicalTrials.gov Identifier: NCT03661801|
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : October 10, 2018
|Condition or disease|
|Respiratory Disease Pleural Effusion Lung Cancer|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||A Prospective Observational Study Examining the Clinical Utility of Novel Pleural Fluid, Biopsy and Serum Bio Markers for the Investigation of Pleural Effusions|
|Actual Study Start Date :||October 26, 2017|
|Estimated Primary Completion Date :||September 25, 2021|
|Estimated Study Completion Date :||September 25, 2021|
- Protein expression levels of specific biomarkers [ Time Frame: At enrolment ]
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:
- Brain natriuretic peptide
- 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
- The analysis of protein and gene expression profile in cell subpopulation of pleural fluid, pleural and endobronchial biopsies and blood samples. [ Time Frame: At enrolment ]To correlate gene expression, immune sub population, protein levels with pleural disease prognoses
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661801
|Contact: Tomas Bailey||+441865 email@example.com|
|Contact: Emma Hedley||+441865 227456||Emma.Hedley@ouh.nhs.uk|
|Oxford University Hospitals NHS Foundation Trust||Recruiting|
|Oxford, Oxfordshire, United Kingdom, OX3 7LE|
|Contact: Tomas P Bailey +441865225205 firstname.lastname@example.org|
|Contact: Emma Hedley +441865225205 Emma.Hedley@ouh.nhs.uk|
|Principal Investigator: Ioannis Psallidas|
|Principal Investigator:||Ioannis Psallidas||University of Oxford|