Status:
RECRUITING
Augmented Response of Volatile Biomarkers in Assessment of Oesophagogastric Cancer (AROMA 1 / BIORESOURCE)
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Imperial College Healthcare NHS Trust
Newcastle-upon-Tyne Hospitals NHS Trust
Conditions:
Volatile Organic Compounds
Microbiome
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Cancer of the stomach and oesophagus is among the world's top five cancers. Survival rates are very poor as the disease presents late and early symptoms are non-specific. The study team has developed ...
Detailed Description
AROMA 1: A total of 648 patients will be recruited for development of an augmented breath test to detect oesophageal and gastric cancer at early stages of disease. Three groups, each containing 216 pa...
Eligibility Criteria
Inclusion
- AROMA 1 Inclusion Criteria:
- Aged 18-90years
- Oesophageal/gastric cancer cohort: participants with biopsy proven adenocarcinoma who are treatment naïve
- 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:
- Oesophageal squamous cell carcinoma
- Previous oesophageal and gastric resection
- Received neoadjuvant chemotherapy for oesophageal or gastric cancer
- History of another cancer within three years
- Any form of oesophageal dysplasia (control cohort only)
- Previously diagnosed with Barrett's oesophagus (control cohort only)
- Active infection, on immunosuppressive medications or antibiotic therapy within the last 8 weeks
- Participants with co-morbidities preventing breath collection
- 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
- Unable or unwilling to provide informed written consent
- Pregnant participants
- BIORESOURCE inclusion criteria:
- Aged 18- 90years
- Oesophageal/gastric cancer cohort: participants with biopsy proven adenocarcinoma who are treatment naïve
- Oesophageal/gastric control cohort: participants with normal or benign upper gastrointestinal disease determined on: • Planned endoscopy
- BIORESOURCE exclusion criteria:
- Oesophageal squamous cell carcinoma
- Previous oesophageal and gastric resection
- Received neoadjuvant chemotherapy for oesophageal or gastric cancer
- History of another cancer within five years
- Any form of oesophageal dysplasia (oesophageal/gastric control cohorts only)
- Previously diagnosed with Barrett's oesophagus (oesophageal/gastric control cohorts only)
- Active infection, on immunosuppressive medications or antibiotic therapy within the last 8 weeks
- Participants with co-morbidities preventing breath collection
- Unable or unwilling to provide informed written consent
- Pregnant participants
Exclusion
Key Trial Info
Start Date :
February 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
648 Patients enrolled
Trial Details
Trial ID
NCT05412758
Start Date
February 28 2022
End Date
October 1 2025
Last Update
January 31 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Imperial College NHS Foundation Trust
London, United Kingdom, W12 0HS