VOC - Breath Biomarker Detection - Pilot Study
Research type
Research Study
Full title
Breath Biomarker Detection in Patients with Suspected Breast Cancer: a Pilot Study
IRAS ID
318636
Contact name
Jenny Piper
Contact email
Sponsor organisation
York & Scarborough Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Fewer than 8% of people currently referred with suspected breast cancer actually have cancer. A screening test is needed to better identify those at risk.
Human breath contains within it an 'odour fingerprint' that reflects the health status of the individual. This fingerprint is made up of chemicals called volatile organic compounds (VOC). These can be detected in the laboratory and can act as a ‘biomarker’ to indicate abnormal processes, conditions or diseases.
Our collaborators at the University of York have recently identified a VOC fingerprint in breast cancer tissue models that can be accurately and consistently distinguished from the VOC of normal breast tissue. We want to explore whether these experimental findings can be translated into clinical practice.
We aim to conduct a pilot study at York Teaching Hospital to recruit sixty patients referred to the Breast Clinic with suspected breast cancer. Consenting patients will provide a breath sample and have their breath-function tested. They will also complete a questionnaire and have their clinical details recorded. Their breath sample will then be transported to the University for VOC fingerprint analysis. The analysis will then be compared with the clinical details to establish the accuracy of diagnosis, if any.
We hope that this pilot study will allow us to identify a breath-derived VOC biomarker screening tool for breast cancer detection. Being non-invasive and simple to capture, breath would be an attractive screening tool. The system of breath collection developed by the University is not only simple, but also quick and reproducible. It could be used in a Breast Clinic setting or a GP practice.
The results of this pilot study would underpin a future research application for a formal diagnostic accuracy study, both for patients with symptoms suggestive of breast cancer, and for women using the breast screening service.
REC name
London - Queen Square Research Ethics Committee
REC reference
22/PR/1228
Date of REC Opinion
12 Jan 2023
REC opinion
Further Information Favourable Opinion