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

NCT03661801 | Completed

• 1 other identifier: INVEST Version 1.0
• Study Type: observational
• Target: 313
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Disease; Pleural Effusion; Lung Cancer

Keywords

Respiratory; Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The analysis of protein and gene expression profile in cell subpopulation of pleural fluid, pleural and endobronchial biopsies and blood samples.

  At enrolment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Inability to give written informed consent
• Inability to obtain pleural fluid, blood, endobronchial or pleural biopsies as applicable

Sponsors & Collaborators

• University of Oxford: lead
• Rocket Medical plc: collaborator

Study Sites (1)

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

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

MeSH Terms

Conditions

Respiration Disorders; Pleural Effusion; Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases

Study Officials

• Najib Rahman

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 7, 2018
• Study Start: October 26, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 5, 2020

Record last verified: 2020-11

Locations

GB (1)