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

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ClinicalTrials.gov Identifier: NCT03661801
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : October 10, 2018
Sponsor:
Collaborator:
Rocket Medical plc
Information provided by (Responsible Party):
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.

Condition or disease
Respiratory Disease Pleural Effusion Lung Cancer

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
Estimated Enrollment : 300 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 : October 26, 2017
Estimated Primary Completion Date : September 25, 2021
Estimated Study Completion Date : September 25, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy




Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661801


Contacts
Contact: Tomas Bailey +441865 225205 tomas.bailey@ouh.nhs.uk
Contact: Emma Hedley +441865 227456 Emma.Hedley@ouh.nhs.uk

Locations
United Kingdom
Oxford University Hospitals NHS Foundation Trust Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 7LE
Contact: Tomas P Bailey    +441865225205    tomas.bailey@ouh.nhs.uk   
Contact: Emma Hedley    +441865225205    Emma.Hedley@ouh.nhs.uk   
Principal Investigator: Ioannis Psallidas         
Sponsors and Collaborators
University of Oxford
Rocket Medical plc
Investigators
Principal Investigator: Ioannis Psallidas University of Oxford

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03661801     History of Changes
Other Study ID Numbers: INVEST Version 1.0
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
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
Pleural Diseases