An observational study in Respiratory Disease, Pleural Effusion and Lung Cancer, sponsored by University of Oxford. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-05.
Sponsored by University of Oxford · Observational
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.
A prospective observation study examining the clinical utility of novel pleural fluid, biopsy and serum biomarkers for the investigation of pleural effusions (INVEST). The INVEST study will collect blood, pleural fluid and tissue samples from donors, allowing the opportunity to apply several novel blood and pleural fluid tests with interpretation of results in the context of clinical data and diagnostic suspicion. Through the prospective application of multiple tests, we aim to validate the sensitivity and specificity of existing biomarkers and identify novel markers that aid in the diagnostic pathway of pleural diseases. Because samples and data will be stored for future use, many other different tests, methods and techniques may be used in the future to provide information that we cannot foresee.
324 studies on the registry are indexed under Pleural Effusion; 62 are open to participants now.
This study's enrollment of 313 is above the median of 103 across 102 observational studies indexed under Pleural Effusion.
Browse Pleural Effusion studies →University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.
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This is a prospective single centre study looking to recruit 300 participants to help prospectively evaluate the sensitivity and specificity of known diagnostic biomarkers and discover novel biomarkers in pleural diseases. Patients aged 18 or over, requiring investigation and/or management of any undiagnosed pleural effusion or pleural thickening will be approached about the study within Oxford University Hospital NHS Foundation Trust.
Undiagnosed pleural effusion or pleural thickening requiring investigation by one of the following:
Exclusion Criteria:
Protein expression levels of specific biomarkers
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
Time frame: At enrolment
The analysis of protein and gene expression profile in cell subpopulation of pleural fluid, pleural and endobronchial biopsies and blood samples.
To correlate gene expression, immune sub population, protein levels with pleural disease prognoses
Time frame: At enrolment
Plan to share: Undecided
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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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University of Oxford