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

A Prospective Observational Study Examining the Clinical Utility of Novel Pleural Fluid, Biopsy and Serum Bio Markers for the Investigation of Pleural Effusions

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Respiratory Disease; Pleural Effusion

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 Type: Observational
• Enrollment (Actual): 313

Contacts and Locations

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 7LE
      • Oxford University Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: 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	At enrolment

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: Rocket Medical plc

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 4, 2018
• First Posted (Actual): September 7, 2018

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Respiratory; Pleural Effusion
• Additional Relevant MeSH Terms: Pleural Diseases; Respiration Disorders; Respiratory Tract Diseases; Pleural Effusion
• Other Study ID Numbers: INVEST Version 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No