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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorImperial College London

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Oral Stimulant Drink

    Dietary supplement

    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

Treatment groups

648 Participants
are divided into 3 treatment groups
Group A: Oesophageal/GOJ cancerExperimental treatment 1 intervention
Group B: Gastric cancerExperimental treatment 1 intervention
Group C: Control/ normal patients with upper gastrointestinal symptomsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
18 months

Secondary outcomes

1

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

Time frame
18 months
2

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.

Time frame
18 months
3

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

Time frame
18 months
4

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

Time frame
18 months

Other outcomes

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