Clinical trial · Observational
AUGMENTED RESPONSE OF VOLATILE BIOMARKERS IN THE ASSESSMENT OF OESOPHAGOGASTRIC CANCER (AROMA2)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breath Tests | — | UNRESOLVED | — |
| Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma | — | UNRESOLVED | — |
| Oesophageal Adenocarcinoma | — | UNRESOLVED | — |
| Oesophageal Cancer Nos | — | UNRESOLVED | — |
| Oesophageal Junction Cancer | — | UNRESOLVED | — |
| OESOPHAGO-GASTRIC CARCINOMA | — | UNRESOLVED | — |
| Volatile Organic Compound | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breath Test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants referred along upper gastrointestinal suspected cancer pathways
- description
- Participants referred by GPs to secondary care for the reference test (i.e. upper gastrointestinal endoscopy, CT/MRI/ultrasound ± histological/cytology). Participants will be followed up (within 3 months) to determine whether they had a diagnosis of upper gastrointestinal adenocaricinoma or a normal/benign diagnosis.
- interventionNames
- Diagnostic Test: Breath Test
Primary outcomes (1)
- measure
- Validation of VOC biomakrer model for Upper GI Adenocarcinoma
- timeFrame
- 3 years
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Previous oesophageal or gastric resection * History of cancer within three years (other than non-melanoma skin cancers) * Co-morbidities preventing breath collection * Pregnant participants * Allergies to any of the constituents of the nutrient drink including glucose, glycerol, iron sulphate, Maltodextrin (Corn, Potato), Xanthan Gum, Potassium Chloride, tyrosine, phenylalanine, and glutamic acid * Unable or unwilling to provide informed written consent.
References
Publications (0)
Data not yet available