Non-invasive breath test for early detection of oesophageal and gastric cancer
Augmented Response of Volatile Biomarkers in Assessment of Oesophagogastric Cancer
This study is testing a new breath test to see if it can help find oesophageal and stomach cancers early in people who have symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 648 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (London) |
| Trial ID | NCT05412758 on ClinicalTrials.gov |
What this trial studies
This study aims to develop an enhanced breath test that detects volatile organic compounds associated with oesophageal and gastric cancers. A total of 648 patients will be recruited, including those with confirmed cancer and control patients with upper gastrointestinal symptoms. Participants will provide breath samples before and after consuming a standard nutrient drink, which may increase the production of these compounds. The samples will be analyzed using advanced chromatographic and mass spectrometric techniques to improve diagnostic accuracy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-90 with biopsy-proven adenocarcinoma of the oesophagus or stomach, as well as those with benign upper gastrointestinal conditions.
Not a fit: Patients with oesophageal squamous cell carcinoma, previous resections, or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this test could lead to earlier detection of oesophageal and gastric cancers, potentially improving survival rates.
How similar studies have performed: While similar approaches to cancer detection using breath analysis have been explored, this specific method is innovative and not widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
AROMA 1 Inclusion Criteria: 1. Aged 18-90years 2. Oesophageal/gastric cancer cohort: participants with biopsy proven adenocarcinoma who are treatment naïve 3. Control cohort: participants with normal or benign upper gastrointestinal disease determined on: • Endoscopy within 1 year • Planned endoscopy AROMA 1 Exclusion criteria: Patients with the following characteristics will not be eligible for inclusion in this study: 1. Oesophageal squamous cell carcinoma 2. Previous oesophageal and gastric resection 3. Received neoadjuvant chemotherapy for oesophageal or gastric cancer 4. History of another cancer within three years 5. Any form of oesophageal dysplasia (control cohort only) 6. Previously diagnosed with Barrett's oesophagus (control cohort only) 7. Active infection, on immunosuppressive medications or antibiotic therapy within the last 8 weeks 8. Participants with co-morbidities preventing breath collection 9. Allergies to any of the constituents of the nutrient drink including glucose, glycerol, iron sulphate, Maltodextrin (Corn, Potato), Xanthan Gum, Potassium Chloride, tyrosine, phenylalanine, and glutamic acid 10. Unable or unwilling to provide informed written consent 11. Pregnant participants BIORESOURCE inclusion criteria: 1. Aged 18- 90years 2. Oesophageal/gastric cancer cohort: participants with biopsy proven adenocarcinoma who are treatment naïve 3. Oesophageal/gastric control cohort: participants with normal or benign upper gastrointestinal disease determined on: • Planned endoscopy BIORESOURCE exclusion criteria: 1. Oesophageal squamous cell carcinoma 2. Previous oesophageal and gastric resection 3. Received neoadjuvant chemotherapy for oesophageal or gastric cancer 4. History of another cancer within five years 5. Any form of oesophageal dysplasia (oesophageal/gastric control cohorts only) 6. Previously diagnosed with Barrett's oesophagus (oesophageal/gastric control cohorts only) 7. Active infection, on immunosuppressive medications or antibiotic therapy within the last 8 weeks 8. Participants with co-morbidities preventing breath collection 9. Unable or unwilling to provide informed written consent 10. Pregnant participants
Where this trial is running
London
- Imperial College NHS Foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: George Hanna, PhD, FRCS — Imperial College London
- Study coordinator: Ayushi Pabari, BSc, MSc
- Email: aroma@imperial.ac.uk
- Phone: 02075948847
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.