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| Name | Class |
|---|---|
| Rocket Medical plc | OTHER |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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:
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 | At enrolment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At enrolment |
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Inclusion Criteria:
Undiagnosed pleural effusion or pleural thickening requiring investigation by one of the following:
Suspected lung cancer undergoing bronchoscopy and biopsies.
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Najib Rahman | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford University Hospitals NHS Foundation Trust | Oxford | Oxfordshire | OX3 7LE | United Kingdom |
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| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D010996 | Pleural Effusion |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D010995 | Pleural Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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For patients with undiagnosed pleural effusion or thickening, an extra 10ml blood and 10 ml fluid will be taken for study purposes when these samples are collected for clinical purposes. For these patients undergoing pleural biopsy, as part of their clinical care, an extra sample will be taken for the trial. For patients with suspected lung cancer, one extra biopsy sample will be taken when the participants have their diagnostic bronchoscopic biopsy
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |