Breath test for detecting oesophageal cancer
Volatile Organic Compounds as Breath Biomarkers in Squamous Oesophageal Neoplasms
This study is testing a breath test to see if it can help find oesophageal cancer early in people who have vague symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 518 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 13 sites (London, Greater London and 12 other locations) |
| Trial ID | NCT06169163 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a breath test that can detect Oesophageal Squamous Cell Carcinoma (OSCC) in patients with non-specific symptoms. A total of 518 participants will be recruited, divided into a cancer group with confirmed OSCC and a control group with normal or benign upper gastrointestinal conditions. Participants will provide breath samples, which will be analyzed for volatile organic compounds (VOCs) at Imperial College London. The goal is to create a non-invasive early detection method for OSCC, improving survival rates.
Who should consider this trial
Good fit: Ideal candidates include patients with treatment-naive, histopathology confirmed OSCC and those undergoing endoscopy for upper GI symptoms with normal or benign findings.
Not a fit: Patients who have received treatment for OSCC or have other specific exclusions such as Barrett's oesophagus or a history of another cancer in the last five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this breath test could significantly enhance early detection of oesophageal cancer, leading to improved survival rates.
How similar studies have performed: While breath testing for cancer detection is an emerging field, this specific approach using VOCs for OSCC is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Participants with all the following characteristics will be eligible for inclusion in the study: 1. Cancer cohort (n=259): Patients with treatment naïve, histopathology confirmed OSCC. 2. Control cohort (n=259): Patients who have undergone or are undergoing an endoscopy (OGD) as part of their investigation for upper GI symptoms and are found to have either: * A normal upper gastrointestinal tract * Benign upper gastrointestinal disease Exclusion Criteria: Participants with the following characteristics will not be eligible for inclusion in the study: 1. Received some form of treatment (chemotherapy, radiotherapy, immunotherapy, endoscopic resection, or surgery) for OSCC 2. History of another cancer in the last five years 3. Non-squamous cell oesophageal cancer 4. Barrett's oesophagus (with or without dysplasia) 5. Previous oesophageal or gastric resection 6. Unable to provide written consent or lack capacity. 7. Pregnant women
Where this trial is running
London, Greater London and 12 other locations
- Imperial College Healthcare NHS Trust — London, Greater London, United Kingdom (Recruiting)
- Hull University Teaching Hospitals NHS Trust — Cottingham, Hull, United Kingdom (Recruiting)
- Cardiff and Vale University Health Board — Cardiff, United Kingdom (Not_yet_recruiting)
- Velindre NHS Trust — Cardiff, United Kingdom (Not_yet_recruiting)
- University Hospitals Coventry and Warwickshire NHS Trust — Coventry, United Kingdom (Recruiting)
- University Hospitals of Leicester NHS Foundation Trust — Leicester, United Kingdom (Recruiting)
- Liverpool University Hospitals NHS Foundation Trust — Liverpool, United Kingdom (Not_yet_recruiting)
- The Clatterbridge Cancer Centre NHS Foundation Trust — Liverpool, United Kingdom (Recruiting)
- Bedfordshire Hospitals NHS Foundation Trust — Luton, United Kingdom (Not_yet_recruiting)
- Newcastle Upon Tyne Hospitals NHS Trust — Newcastle, United Kingdom (Recruiting)
- Norfolk and Norwich University Hospitals NHS Foundation Trust — Norwich, United Kingdom (Recruiting)
- Oxford University Hospitals NHS Trust — Oxford, United Kingdom (Recruiting)
- Portsmouth Hospitals University NHS Trust — Portsmouth, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Sameera Sharma, MBBS; MRCS
- Email: vison@imperial.ac.uk
- Phone: 07576583519
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.