Actively Recruiting
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
4 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 type of cancer affecting the food pipe, with poor survival rates when detected late. Early detection greatly improves survival, but current methods like endoscopy are invasive and uncomfortable. Researchers are evaluating a breath test that detects volatile organic compounds produced by the cancer, aiming to offer a non-invasive, simple, and cost-effective way to identify OSCC early in patients with non-specific symptoms. This study involves two groups: one with patients newly diagnosed with OSCC who have not yet received treatment, and a control group undergoing endoscopy for upper gastrointestinal symptoms but without cancer. Participants will provide breath samples by exhaling into single-use collection bags twice, with the samples then analyzed at a laboratory to identify cancer-related compounds. Room air samples will also be collected for comparison. Participants will be asked to provide breath samples after maintaining a clear fluid diet for at least six hours. The study will measure the accuracy of the breath test in detecting OSCC and assess factors that might affect the test results. The total study duration for outcome measurement is 36 months, supported by multiple centers and led by Imperial College London.
CONDITIONS
Brief Title
Volatile Organic Compounds as Breath Biomarkers in Squamous Oesophageal Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with treatment naive, histopathology confirmed oesophageal squamous cell carcinoma
- Patients undergoing or having undergone upper gastrointestinal endoscopy for symptoms
- Control patients with normal upper gastrointestinal tract or benign upper gastrointestinal disease
- Age between 18 and 90 years
- Ability to provide written consent
You will not qualify if you...
- Received treatment for oesophageal squamous cell carcinoma (chemotherapy, radiotherapy, immunotherapy, endoscopic resection, or surgery)
- History of another cancer in the last five years
- Non-squamous cell oesophageal cancer
- Barrett's oesophagus with or without dysplasia
- Previous oesophageal or gastric surgery
- Unable to provide written consent or lacking capacity
- Pregnant women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants provide breath samples by exhaling into single-use breath collection bags. This includes transferring volatile organic compounds onto thermal desorption tubes for later analysis.
1 visit (in-person)
Duration - Up to 36 months
Participants are observed over time to evaluate the presence of breath biomarkers related to oesophageal squamous cell carcinoma and effects of confounding variables.
No additional visits required
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
Research Team
S
Sameera Sharma, MBBS; MRCS
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here