Breath test for early detection of oesophageal cancer and dysplasia
Non-invasive Testing for the Diagnosis of Early Oesophageal Cancer and Barrett's Dysplasia
This study is testing a breath test to see if it can help find early signs of oesophageal cancer and dysplasia in patients who are already scheduled for a procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Female |
| Sponsor | Imperial College London Academic / other |
| Locations | 12 sites (Birmingham and 11 other locations) |
| Trial ID | NCT04001478 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of a breath test in detecting early-stage oesophageal cancer and Barrett's high-grade dysplasia. Patients scheduled for gastroscopy or elective surgery for confirmed early-stage oesophageal adenocarcinoma or dysplasia will provide breath samples. The samples will undergo analysis using mass spectrometry to identify volatile biomarkers that differentiate between cancerous and non-cancerous conditions. The goal is to improve early diagnosis and potentially enhance survival rates for patients at risk.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 who are undergoing gastroscopy or elective resection for confirmed early-stage oesophageal adenocarcinoma or high-grade dysplasia.
Not a fit: Patients under 18 or over 90 years of age, or those unable to provide informed consent, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of oesophageal cancer, improving patient outcomes and survival rates.
How similar studies have performed: While the use of breath tests for cancer detection is an emerging field, this specific approach is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥18 years and ≤90 years of age * Undergoing gastroscopy or elective resection of histologically confirmed oesophageal adenocarcinoma/ high grade dysplasia * Fasted \>6 hours * Able to provide informed written consent Exclusion Criteria: * Any patient \<18 years or \>90 years of age. * Lacks capacity or is unable to provide informed written consent.
Where this trial is running
Birmingham and 11 other locations
- University Hospitals Birmingham Nhs Foundation Trust — Birmingham, United Kingdom (Recruiting)
- University Hospital Dorset NHS Foundation Trust — Bournemouth, United Kingdom (Recruiting)
- University Hospital Coventry and Warwickshire — Coventry, United Kingdom (Recruiting)
- Royal Liverpool University Hospital — Liverpool, United Kingdom (Recruiting)
- University College London Hospitals Nhs Foundation Trust — London, United Kingdom (Recruiting)
- Guy'S and St Thomas' Nhs Foundation Trust — London, United Kingdom (Recruiting)
- Imperial College Healthcare Trust — London, United Kingdom (Recruiting)
- Newcastle Hospital NHS Foundation Trust — Newcastle Upon Tyne, United Kingdom (Recruiting)
- Nottingham University Hospitals Nhs Trust — Nottingham, United Kingdom (Recruiting)
- Portsmouth Hospitals Nhs Trust — Portsmouth, United Kingdom (Recruiting)
- University Hospital Southampton NHS Foundation Trust — Southampton, United Kingdom (Recruiting)
- Betsi Cadwaladr University Health Board — Wrexham, United Kingdom (Recruiting)
Study contacts
- Principal investigator: George B Hanna, FRCS PhD — Imperial College London
- Study coordinator: Sara H Jamel, MBBS MRCS
- Email: s.jamel@imperial.ac.uk
- Phone: 02033126328
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.