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

University of Oxford

Status: Completed

Conditions: Respiratory Disease; Pleural Effusion; Lung Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT03661801

INVEST Version 1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 313 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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