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

Lung Cancer Clinical Trial

— INVEST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03661801
• Other study ID #: INVEST Version 1.0
• Status: Completed
• Start date: October 26, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2020
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Pleural Effusion
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Locations

Country	Name	City	State
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford	Oxfordshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Rocket Medical plc

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The analysis of protein and gene expression profile in cell subpopulation of pleural fluid, pleural and endobronchial biopsies and blood samples.	To correlate gene expression, immune sub population, protein levels with pleural disease prognoses	At enrolment