Novel Pleural Fluid, Biopsy and Serum Biomarkers for the Investigation of Pleural Effusions

Completed

• Conditions: Pleural Effusion; Respiratory Disease; Lung Cancer

• Registration Number: NCT03661801
• Lead Sponsor: University of Oxford

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-10-26
• Study First Submitted: 2018-09-04
• Study First Submitted QC: 2018-09-04
• Study First Posted: 2018-09-07
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 313

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.

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Exclusion Criteria

• Inability to give written informed consent
• Inability to obtain pleural fluid, blood, endobronchial or pleural biopsies as applicable

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Protein expression levels of specific biomarkers	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: * 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 Outcome Measures

Name	Time	Method
The analysis of protein and gene expression profile in cell subpopulation of pleural fluid, pleural and endobronchial biopsies and blood samples.	At enrolment	To correlate gene expression, immune sub population, protein levels with pleural disease prognoses

Trial Locations

Locations (1)

Oxford University Hospitals NHS Foundation Trust; 🇬🇧 Oxford, Oxfordshire, United Kingdom