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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
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 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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Breath Test

    Diagnostic 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.

Treatment groups

6,000 Participants
are divided into 1 treatment group
Group A: Participants referred along upper gastrointestinal suspected cancer pathways1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
3 years

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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