Actively Recruiting

Age: 18Years - 90Years
All Genders
NCT06169163

Volatile Organic Compounds as Breath Biomarkers in Squamous Oesophageal Neoplasms

Led by Imperial College London · Updated on 2025-05-02

518

Participants Needed

13

Research Sites

160 weeks

Total Duration

On this page

Sponsors

I

Imperial College London

Lead Sponsor

I

Imperial College Healthcare NHS Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Volatile Organic Compounds as Breath Biomarkers in Squamous Oesophageal Neoplasms

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with treatment-naive, histopathology confirmed oesophageal squamous cell carcinoma (cancer cohort).
  • Patients undergoing or who have undergone upper gastrointestinal endoscopy for symptoms and found to have a normal upper GI tract or benign upper GI disease (control cohort).
  • Age between 18 and 90 years.
Not Eligible

You will not qualify if you...

  • Received any treatment for oesophageal squamous cell carcinoma such as chemotherapy, radiotherapy, immunotherapy, endoscopic resection, or surgery.
  • History of another cancer within the last five years.
  • Diagnosis of non-squamous cell oesophageal cancer.
  • Barrett's oesophagus, with or without dysplasia.
  • Previous oesophageal or gastric surgery.
  • Unable to provide written consent or lacks capacity.
  • Pregnant women.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 13 locations

1

Imperial College Healthcare NHS Trust

London, Greater London, United Kingdom, W12 0NN

Actively Recruiting

2

Hull University Teaching Hospitals NHS Trust

Cottingham, Hull, United Kingdom

Actively Recruiting

3

Cardiff and Vale University Health Board

Cardiff, United Kingdom

Not Yet Recruiting

4

Velindre NHS Trust

Cardiff, United Kingdom

Not Yet Recruiting

5

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, United Kingdom

Actively Recruiting

6

University Hospitals of Leicester NHS Foundation Trust

Leicester, United Kingdom

Actively Recruiting

7

Liverpool University Hospitals NHS Foundation Trust

Liverpool, United Kingdom

Not Yet Recruiting

8

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, United Kingdom

Actively Recruiting

9

Bedfordshire Hospitals NHS Foundation Trust

Luton, United Kingdom

Not Yet Recruiting

10

Newcastle Upon Tyne Hospitals NHS Trust

Newcastle, United Kingdom

Actively Recruiting

11

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, United Kingdom

Actively Recruiting

12

Oxford University Hospitals NHS Trust

Oxford, United Kingdom

Actively Recruiting

13

Portsmouth Hospitals University NHS Trust

Portsmouth, United Kingdom

Not Yet Recruiting

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Research Team

S

Sameera Sharma, MBBS; MRCS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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