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

Sponsor
University of Oxford (Other)
Overall Status
Completed
CT.gov ID
NCT03661801
Collaborator
Rocket Medical plc (Other)
313
Enrollment
1
Location
26.2
Actual Duration (Months)
12
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    313 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Observational Study Examining the Clinical Utility of Novel Pleural Fluid, Biopsy and Serum Bio Markers for the Investigation of Pleural Effusions
    Actual Study Start Date :
    Oct 26, 2017
    Actual Primary Completion Date :
    Dec 31, 2019
    Actual Study Completion Date :
    Dec 31, 2019

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oxford University Hospitals NHS Foundation Trust Oxford Oxfordshire United Kingdom OX3 7LE

    Sponsors and Collaborators

    • University of Oxford
    • Rocket Medical plc

    Investigators

    • Principal Investigator: Najib Rahman, University of Oxford

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Oxford
    ClinicalTrials.gov Identifier:
    NCT03661801
    Other Study ID Numbers:
    • INVEST Version 1.0
    First Posted:
    Sep 7, 2018
    Last Update Posted:
    Nov 5, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Oxford
    Respiratory
    Pleural Effusion
    Additional relevant MeSH terms:
    Pleural Effusion
    Respiration Disorders
    Respiratory Tract Diseases

    Study Results

    No Results Posted as of Nov 5, 2020