Augmented Response of Volatile Biomarkers in Assessment of Oesophagogastric Cancer (AROMA 1 / BIORESOURCE)

Launched by IMPERIAL COLLEGE LONDON · Jun 7, 2022

Keywords

ClinConnect Summary

The AROMA 1 / BIORESOURCE trial is studying a new, non-invasive breath test designed to help detect stomach and oesophageal cancers earlier. This test works by analyzing volatile organic compounds—substances that can be found in the breath and are produced by cancer cells and related bacteria in the gut. The researchers believe that by using simple nutrients before the breath test, they might increase the amount of these compounds, leading to a more accurate diagnosis of the disease.

To participate in the trial, you need to be between 18 and 90 years old and either have a confirmed diagnosis of oesophageal or gastric adenocarcinoma (a type of cancer) or have a benign condition in the upper gastrointestinal tract. Unfortunately, if you have certain other health issues, like specific types of cancer or recent treatments that could affect the study results, you may not be eligible. If you join the trial, you can expect to provide breath samples after consuming a nutrient drink, and your participation could help improve early detection methods for these serious cancers.

Gender

ALL

Eligibility 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