RECRUITINGINTERVENTIONAL
Augmented Response of Volatile Biomarkers in Assessment of Oesophagogastric Cancer (AROMA 1 / BIORESOURCE)
Augmented Response of Volatile Biomarkers in Assessment of Oesophagogastric Cancer
About This Trial
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 a non-invasive test for cancers of the stomach and oesophagus based on the detection of volatile organic compounds in exhaled breath. These compounds are known to be produced by both cancers as well as cancer associated bacteria within the gut. The proposed innovation is to improve the accuracy of this test by investigating whether simple metabolic substrates can increase the production of these volatile organic compounds by both the tumour and its associated bacteria.
Who May Be Eligible (Plain English)
AROMA 1 Who May Qualify:
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 Who Should NOT Join This Trial:
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 Who May Qualify:
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 Who Should NOT Join This Trial:
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)
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DIETARY_SUPPLEMENT
Oral Stimulant Drink
For the AROMA 1 study patients will be requested to consume a nutrient drink (approximately 200 ml) that includes natural ingredients found within a typical human diet. Following consumption of the drink, serial breath tests will be performed to determine varying levels of VOC production in breath
Locations (1)
Imperial College NHS Foundation Trust
London, United Kingdom