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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Oesophageal squamous cell carcinoma
Previous oesophageal and gastric resection
Received neoadjuvant chemotherapy for oesophageal or gastric cancer
History of another cancer within three years
Trial design
Single group
Treatments tested in this trial
Oral Stimulant Drink
Dietary supplementFor 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
Treatment groups
Trial outcomes
Primary outcomes
Efficacy of an oral nutrient drink to stimulate the production of volatile organic compounds detected in the breath.
Efficacy of the oral stimulant drink will be measured by comparing the relative abundance of certain volatile organic compounds (measured in ppt) detected in the breath. Breath analysis will be performed with the help of Gas Chromatography- Mass Spectrometry (GC-MS)
Secondary outcomes
Volatile metabolites present in breath of subjects with oesophagogastric cancer and controls
GC-MS will be used to determine the presence of certain cancer associated volatile organic compounds in breath
Volatile metabolites present in headspace of the urine of subjects with oesophagogastric cancer and controls
Headspace sampling techniques will be used for headspace collection from urine samples. GC-MS will be used to determine the presence of certain cancer associated volatile organic compounds within the headspace of urine.
Determination of bacterial species and cancer associated volatile compound production from saliva samples of subjects with oesophagogastric cancer.
Bacterial species will be determined using sequencing techniques such as 16s or whole genome sequencing. Bacteria within the saliva samples will be cultured and species isolated. Once isolated, cancer associated species will be re-cultured within a controlled environment. Headspace and media sampling will be performed to determine the volatile metabolites present using GC-MS and LC-MS techniques
Determination of bacterial species and cancer associated volatile compound production from tissue samples of subjects with oesophagogastric cancer
Bacterial species will be determined using sequencing techniques such as 16s or whole genome sequencing. Tissue and bacteria from biopsies will be separated. Bacteria derived from tissue samples will be cultured and species isolated. Once isolated, cancer associated species will be re-cultured within a controlled environment. Headspace and media sampling will be performed to determine the volatile metabolites present using GC-MS and LC-MS techniques
Sponsors and contacts
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Imperial College London
Lead sponsor
Imperial College Healthcare NHS Trust
Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborator
University Hospital Birmingham NHS Foundation Trust
Collaborator
University Hospital Southampton NHS Foundation Trust
Collaborator
Norfolk and Norwich University Hospitals NHS Foundation Trust
Collaborator
Nottingham University Hospitals NHS Trust
Collaborator
University Hospital Plymouth NHS Trust
Collaborator
Royal Surrey County Hospital NHS Foundation Trust
Collaborator
University Hospitals Coventry and Warwickshire NHS Trust
Collaborator
Guy's and St Thomas' NHS Foundation Trust
Collaborator
Portsmouth Hospitals NHS Trust
Collaborator
Barking, Havering and Redbridge University Hospitals NHS Trust
Collaborator
Northern Care Alliance NHS Foundation Trust
Collaborator
Brighton and Sussex University Hospitals NHS Trust
Collaborator
University College London Hospitals
Collaborator
Cardiff and Vale University Health Board
Collaborator
NHS Lothian
Collaborator
NHS Tayside
Collaborator
York Teaching Hospitals NHS Foundation Trust
Collaborator
The Harley Street Clinic
Collaborator