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 years old.
Participants referred from primary care according to the urgent suspected cancer referral guidelines for potential underlying oesophagogastric cancer a for the reference test (described below).
Willing and able to provide informed written consent to take part in study.
Disqualifiers
Previous oesophageal or gastric resection
History of cancer within three years (other than non-melanoma skin cancers)
Co-morbidities preventing breath collection
Pregnant participants
Trial population
Individuals aged 18 years or over with suspected cancer, referred from primary care for further specialized investigations.
Trial design
Cohort
Prospective
Treatments tested in this trial
Breath Test
Diagnostic testDiagnostic 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.
Treatment groups
Trial outcomes
Primary outcomes
Validation of VOC biomakrer model for Upper GI Adenocarcinoma
GC-MS will be used to confirm the presence of upper gastrointestinal cancer-associated VOCs in order to validate the detection model developed in AROMA1
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: