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NOT YET RECRUITING
NCT07260734

AUGMENTED RESPONSE OF VOLATILE BIOMARKERS IN THE ASSESSMENT OF OESOPHAGOGASTRIC CANCER (AROMA2)

Sponsor: Imperial College London

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

6000

Start Date

2025-12-01

Completion Date

2028-11-01

Last Updated

2025-12-03

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Breath Test

Diagnostic Test: Breath test Participants must be fasted for a minimum of six hours prior to breath sample collection. Breath samples will be collected prior to the reference test for each participant. Participants will then be asked to consume an Oral Stimulant Drink (OSD). The oral stimulant drink (120ml) will be composed of 25g glucose, 25g glycerol, 0.6g iron sulphate, 1.2g of "Thicken Up" thickener and combined amino acids (0.08g tyrosine, 1.8g phenylalanine, 2.1g glutamic acid). Diagnostic Test: Augmented breath test: Participants will then be asked to repeat a breath sample 15 minutes after consumption of the OSD.