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Volatile Organic Compounds as Breath Biomarkers in Squamous Oesophageal Neoplasms
Sponsor: Imperial College London
Summary
Oesophageal Squamous Cell Carcinoma (OSCC) is a cancer of the food pipe that affects around 2000 patients in the UK every year. It is often detected at an advanced stage, resulting in poor survival (5-year survival less than 20%). Early detection can improve survival (5-year survival \>70%). Therefore, early detection is vital to improving survival. There are no national screening guidelines, and an endoscopy (A camera test to look at the food pipe) is the only available test to detect OSCC. Early detection of OSCC is challenging for many reasons. Firstly, early disease symptoms are non-specific, which patients often overlook. Secondly, 'Alarm' symptoms such as weight loss, difficulty swallowing or vomiting blood are signs of advanced stage. Lastly, endoscopy is an invasive test with associated risks and significant discomfort. The investigators propose to develop a breath test for patients with non-specific symptoms. Breath testing has the ideal characteristics for a triage test because it is non-invasive, simple to perform, cost-effective and highly acceptable to patients. The test is based on identifying volatile organic compounds (VOCs, small molecules) that are produced by the cancer and released in breath. The breath test will be offered by General Practitioners (GPs) to patients with non-specific symptoms. Those who test positive will be referred for an urgent camera test, and those who test negative can be reassured.
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
OBSERVATIONAL
Enrollment
518
Start Date
2023-12-01
Completion Date
2026-12-31
Last Updated
2025-05-02
Healthy Volunteers
No
Interventions
Exhaled breath sampling
Participants will maintain a clear fluid diet for a minimum of 6 hours prior to breath collection. Participants will be asked to provide a breath sample by exhaling into single-use breath collection bags. Using a custom designed gas sampling pump, the breath VOCs will be transferred onto TD tubes at a controlled flow rate. This breath sampling procedure will be repeated once. When the participants' breath sampling is complete, room air (Blank) samples must be taken onto additional TD tubes using the same procedure. The TD tubes will be sealed with long-term storage caps using the CapLok Tool.
Locations (13)
Imperial College Healthcare NHS Trust
London, Greater London, United Kingdom
Hull University Teaching Hospitals NHS Trust
Cottingham, Hull, United Kingdom
Cardiff and Vale University Health Board
Cardiff, United Kingdom
Velindre NHS Trust
Cardiff, United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, United Kingdom
University Hospitals of Leicester NHS Foundation Trust
Leicester, United Kingdom
Liverpool University Hospitals NHS Foundation Trust
Liverpool, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom
Bedfordshire Hospitals NHS Foundation Trust
Luton, United Kingdom
Newcastle Upon Tyne Hospitals NHS Trust
Newcastle, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, United Kingdom
Oxford University Hospitals NHS Trust
Oxford, United Kingdom
Portsmouth Hospitals University NHS Trust
Portsmouth, United Kingdom