Volatile Organic Compounds as Breath Biomarkers in Squamous Oesophageal Neoplasms

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorImperial College London

About this trial

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.

Eligibility criteria

Qualifiers

Cancer cohort (n=259): Patients with treatment naïve, histopathology confirmed OSCC.

A normal upper gastrointestinal tract

Benign upper gastrointestinal disease

Disqualifiers

Received some form of treatment (chemotherapy, radiotherapy, immunotherapy, endoscopic resection, or surgery) for OSCC

History of another cancer in the last five years

Non-squamous cell oesophageal cancer

Barrett's oesophagus (with or without dysplasia)

Trial design

Treatments tested in this trial

  • Exhaled breath sampling

Treatment groups

518 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Imperial College London

Lead sponsor

Imperial College Healthcare NHS Trust

Collaborator

Hull University Teaching Hospitals NHS Trust

Collaborator

Norfolk and Norwich University Hospitals NHS Foundation Trust

Collaborator

University Hospitals Coventry and Warwickshire NHS Trust

Collaborator

Oxford University Hospitals NHS Trust

Collaborator

Velindre NHS Trust

Collaborator

Cardiff and Vale University Health Board

Collaborator

Newcastle-upon-Tyne Hospitals NHS Trust

Collaborator

Liverpool University Hospitals NHS Foundation Trust

Collaborator

Bedfordshire Hospitals NHS Foundation Trust

Collaborator

University Hospitals, Leicester

Collaborator

The Clatterbridge Cancer Centre NHS Foundation Trust

Collaborator

Portsmouth Hospitals NHS Trust

Collaborator

University Hospital Plymouth NHS Trust

Collaborator

NHS Tayside

Collaborator

NHS Highlands

Collaborator

The Christie NHS Foundation Trust

Collaborator

North Cumbria University Hospitals NHS Trust

Collaborator

Maidstone & Tunbridge Wells NHS Trust

Collaborator

University Hospitals of Derby and Burton NHS Foundation Trust

Collaborator

Bradford Teaching Hospitals NHS Foundation Trust

Collaborator

East and North Hertfordshire NHS Trust

Collaborator