Non-invasive breath test for early detection of oesophageal and gastric cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.