Augmented response of volatile biomarkers in assessment of oesophagogastric cancer (AROMA 1)

Study ID: 50774
Short Title: Augmented biomarker response in oesophagogastric cancer
Trust Name: PHU,UHS
Recruitment Site: Queen Alexandra Hospital,Southampton General Hospital
Disease Area: Upper GI
Phase: N/A
Expected End Date: 01/09/2024
Postcode: PO6 3LY
SO16 6YD
Contact Name: Amanda Pattie
Contact Email: studysupport1and3.crnwessex@nihr.ac.uk
Active: Yes

Inclusion criteria, exclusion criteria and study summary

1.Male and females aged 18-90 years 2. Patients with biopsy proven oesophageal or gastric adenocarcinoma who have not yet undergone treatment with chemoradiotherapy or surgery 3. Control subjects with symptoms of upper gastrointestinal disease and either a normal upper gastrointestinal tract or benign upper gastrointestinal disease (e.g. gastritis or Barrett’s) as determined at the time of oesophago-gastro-duodenoscopy (± histopathology).

1. Oesophageal squamous cell carcinoma 2. Antibiotic therapy within the last 4 weeks 3. Previous oesophageal and gastric resection 4. Allergy to any of the constituents of the nutrient drink 5. Antibiotic allergy 6. Unable or unwilling to provide informed written consent 7. Pregnant women

Cancer of the stomach and oesophagus (gullet) is among the world's top five cancers. Survival rates are very poor as the disease presents late and early symptoms are non-specific. We have developed a non-invasive test for cancers of the stomach and oesophagus based on the detection of small molecules in exhaled breath that we believe are produced by the cancer as well as gut bacteria that are associated with the cancer. Our proposed innovation is to improve the accuracy of this test by investigating whether the ingredients of simple foods can increase the production of these small molecules. It is expected that cancer and bacteria cells will break down these ingredients to produce larger amounts of the small molecules we have previously measured in the breath, therefore making it easier to detect the cancer. The study will be a prospective multi-centre study, recruiting patients to augment the production of organic compounds in the breath by the consumption of a stimulant drink. Serial breath tests will be performed following this and the collected breath samples will be analysed for organic compounds (associated with cancer and the gut microbiome). In addition to this we aim to establish a comprehensive bioresource of matched samples from patients with oesophageal and gastric cancer as well as controls. Biosamples including breath, urine, saliva, blood, tissue and gastric contents will be collected and analysed to further investigate the metabolic pathways involved in cancer development and organic compound production.

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