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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

313 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-26

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Respiratory Disease Pleural Effusion Lung Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Najib Rahman

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

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Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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INVEST Version 1.0

Identifier Type: -

Identifier Source: org_study_id