Volatile Organic Compounds as Breath Biomarkers in Squamous Oesophageal Neoplasms

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.

Conditions

• Oesophageal Squamous Cell Carcinoma
• Oesophageal Cancer

Interventions

OTHER

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.

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust

  collaborator OTHER

• Hull University Teaching Hospitals NHS Trust

  collaborator OTHER_GOV

• Norfolk and Norwich University Hospitals NHS Foundation Trust

  collaborator OTHER

• University Hospitals Coventry and Warwickshire NHS Trust

  collaborator OTHER

• Oxford University Hospitals NHS Trust

  collaborator OTHER

• Velindre NHS Trust

  collaborator OTHER_GOV

• Cardiff and Vale University Health Board

  collaborator OTHER_GOV

• Newcastle-upon-Tyne Hospitals NHS Trust

  collaborator OTHER

• Liverpool University Hospitals NHS Foundation Trust

  collaborator OTHER_GOV

• Bedfordshire Hospitals NHS Foundation Trust

  collaborator OTHER

• University Hospitals, Leicester

  collaborator OTHER

• The Clatterbridge Cancer Centre NHS Foundation Trust

  collaborator OTHER

• Portsmouth Hospitals NHS Trust

  collaborator OTHER_GOV

• University Hospital Plymouth NHS Trust

  collaborator OTHER

• NHS Tayside

  collaborator OTHER_GOV

• NHS Highlands

  collaborator OTHER

• The Christie NHS Foundation Trust

  collaborator OTHER

• North Cumbria University Hospitals NHS Trust

  collaborator OTHER

• Maidstone & Tunbridge Wells NHS Trust

  collaborator OTHER

• University Hospitals of Derby and Burton NHS Foundation Trust

  collaborator OTHER

• Bradford Teaching Hospitals NHS Foundation Trust

  collaborator OTHER_GOV

• East and North Hertfordshire NHS Trust

  collaborator OTHER_GOV

• Imperial College London

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-01

Primary Completion

2026-11-30

Completion

2026-12-31

Countries

• United Kingdom

Study Locations