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Completed

NCT Number: NCT03661801

Novel Pleural Fluid, Biopsy and Serum Biomarkers 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.

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Key information

Conditions

Respiratory Disease Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pleural Diseases Pleural Effusion Respiration Disorders Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, OX3 7LE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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:
    • 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Rocket Medical plc

Registry information

Official study title

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

Acronym: INVEST

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 7, 2018
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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