Augmented Response of Volatile Biomarkers in Assessment of Oesophagogastric Cancer (AROMA 1 / BIORESOURCE) (AROMA1)

  • STATUS
    Recruiting
  • End date
    Oct 19, 2024
  • participants needed
    648
  • sponsor
    Imperial College London
Updated on 4 October 2022
antibiotics
carcinoma
squamous cell carcinoma
chemoradiotherapy
gastric adenocarcinoma
gastric cancer
cancer chemotherapy
adenocarcinoma
Accepts healthy volunteers

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 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.

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 patients, will be recruited: (i) oesophageal cancer (ii) gastric cancer and (iii) control/normal patients with upper gastrointestinal symptoms. After a baseline breath sample is collected, subjects will then be asked to consume a standard nutirent drink. Further breath samples will be collected at 5, 10 and 15 minutes after consumption of the drink.

Breath samples will be stored on thermal desportion tubes before being transfered to a central laboratory for analysis. Breath samples will be analysed in accordance with existing quality-controlled processes. A combined approach of chromatographic- and real time- mass spectrometric techniques will be applied for VOC profiling.

BIORESOURCE: Samples from 225 patients will be collected in order to establish a biobank for multi-omic analyses. Three groups, each containing 75 patients, will be recruited: (i) oesophageal adenocarcinoma; (ii) gastric adenocarcinoma and (iii) benign conditions/normal gastrointestinal tract with upper gastrointestinal symptoms. The following biosamples will be collected: breath, urine, saliva, blood, tissue and gastric contents. Collected samples will be utilised in a wide range of studies to investigate the mechanisms of VOC production in cancer. The following analyses will be performed: volatalomics, metabonomics/lipidomics, microbiome analysis, transcriptomics and cell culture experiments.

Details
Condition Volatile Organic Compounds, Microbiome, Microbioata, Breath Analysis, Oesophageal Cancer, Gastric Cancer, Volatalomics, Metabonomics/Lipidomics, Microbiome Analysis, Transcriptomics
Treatment Oral Stimulant Drink
Clinical Study IdentifierNCT05412758
SponsorImperial College London
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male and females aged 18-90years
Patients with biopsy proven oesophageal or gastric adenocarcinoma who have not yet undergone treatment with chemoradiotherapy or surgery
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)
Patients and controls with the following characteristics will not be eligible for inclusion
in this study
Oesophageal squamous cell carcinoma
Patients with active infection, on immunosuppressive medications or antibiotic therapy
within the last 8 weeks
Previous oesophageal and gastric resection
History of another cancer within five years
Allergy to any of the constituents of the nutrient drink
Patients who have received or are receiving chemotherapy for oesophago-gastric cancer
Unable or unwilling to provide informed written consent
Pregnant women
Patients with co-morbidities preventing breath collection
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