Diagnosis and endotyping of fungal airways diseases
Research type
Research Study
Full title
Development of a precision diagnostic framework and endotyping (sub-typing) for chronic and allergic fungal airway diseases with a focus on aspergillosis
IRAS ID
345119
Contact name
Ali Nuh
Contact email
Sponsor organisation
Royal Brompton and Harefield Hospitals, Part of GSTT NHS
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
Background
Fungal diseases affect over one billion people globally and kill more than 1.6 million individuals annually. In the UK, fungal diseases and fungal drug resistance are increasing. Allergic and chronic fungal airway diseases (ACFAD) are very common fungal diseases that affect patients with respiratory allergies, like asthmatics, and those with structural airway disease including chronic obstructive pulmonary disease, cavitary pulmonary tuberculosis, bronchiectasis, interstitial lung disease, and cystic fibrosis.
The diagnosis of AC-FAD is very challenging due to their nonspecific clinical and radiological presentations. They are often misdiagnosed as other respiratory diseases such as tuberculosis or malignancy. This may lead to unnecessary medical interventions such as lobectomy, biopsy, and prescription drugs that patients do not need.
Laboratory tests are the cornerstone of the diagnosis of fungal diseases including AC-FAD. However, few reliable tests are available and are almost exclusively validated for acute fungal diseases using blood or respiratory samples obtained invasively through bronchoscopy. Therefore, the performance of these tests on AC-FAD is either unknown or less well understood. In addition, the performance of these tests on sputum samples is almost unexplored.
To improve the diagnosis of AC-FAD, this study will extend the detection of fungal biomarkers to sputum samples- an easily collected, non-invasive, lung-specific samples. It will also investigate and define disease endotypes to enable personalised treatment options.
Research question:
Can sputum diagnose fungal airway diseases?
Aims and Objectives
To improve the diagnosis of allergic and chronic fungal airway diseases by clinically validating new molecular and serological tests to detect fungal biomarker in sputum and investigate fungal airway disease endotypes.
Study design: cohort-based diagnostic accuracy study of sputum fungal biomarkers and patient endotyping.
Sample size: 375 patients, 125 confirmed fungal diseases, 125 patients with suspected fungal disease (for longitudinal study) and 125 control patients.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
24/PR/1579
Date of REC Opinion
28 Feb 2025
REC opinion
Further Information Favourable Opinion