Clinical trial · Interventional
Augmented Response of Volatile Biomarkers in Assessment of Oesophagogastric Cancer (AROMA 1 / BIORESOURCE)
Augmented Response of Volatile Biomarkers in Assessment of Oesophagogastric Cancer
NCT05412758CI-TRIAL-00085368recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 (10)
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 Analysis | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Metabonomics/Lipidomics | — | UNRESOLVED | — |
| Microbioata | — | UNRESOLVED | — |
| Microbiome | — | UNRESOLVED | — |
| Microbiome Analysis | — | UNRESOLVED | — |
| Oesophageal Cancer | — | UNRESOLVED | — |
| Transcriptomics | — | UNRESOLVED | — |
| Volatalomics | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral Stimulant Drink | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Oesophageal/GOJ cancer
- description
- AROMA 1: 216 treatment naive patients with oesophageal/GOJ cancer will be recruited to undertake an augmented breath test. BIORESOURCE: 110 treatment naive patients with oesophageal/GOJ cancer will be recruited for biosample collection at the time of their staging laparoscopy procedure.
- interventionNames
- Dietary Supplement: Oral Stimulant Drink
- type
- EXPERIMENTAL
- label
- Gastric cancer
- description
- AROMA 1: 216 treatment naive patients with gastric cancer will be recruited to undertake an augmented breath test. BIORESOURCE: 75 treatment naive patients with gastric cancer will be recruited for biosample collection at the time of their staging laparoscopy procedure.
- interventionNames
- Dietary Supplement: Oral Stimulant Drink
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
AROMA 1 Inclusion Criteria: 1. Aged 18-90years 2. Oesophageal/gastric cancer cohort: participants with biopsy proven adenocarcinoma who are treatment naïve 3. Control cohort: participants with normal or benign upper gastrointestinal disease determined on: • Endoscopy within 1 year • Planned endoscopy AROMA 1 Exclusion criteria: Patients with the following characteristics will not be eligible for inclusion in this study: 1. Oesophageal squamous cell carcinoma 2. Previous oesophageal and gastric resection 3. Received neoadjuvant chemotherapy for oesophageal or gastric cancer 4. History of another cancer within three years 5. Any form of oesophageal dysplasia (control cohort only) 6. Previously diagnosed with Barrett's oesophagus (control cohort only) 7. Active infection, on immunosuppressive medications or antibiotic therapy within the last 8 weeks 8. Participants with co-morbidities preventing breath collection 9. 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 10. Unable or unwilling to provide informed written consent 11. Pregnant participants BIORESOURCE inclusion criteria: 1. Aged 18- 90years 2. Oesophageal/gastric cancer cohort: participants with biopsy proven adenocarcinoma who are treatment naïve 3. Oesophageal/gastric control cohort: participants with normal or benign upper gastrointestinal disease determined on: • Planned endoscopy BIORESOURCE exclusion criteria: 1. Oesophageal squamous cell carcinoma 2. Previous oesophageal and gastric resection 3. Received neoadjuvant chemotherapy for oesophageal or gastric cancer 4. History of another cancer within five years 5. Any form of oesophageal dysplasia (oesophageal/gastric control cohorts only) 6. Previously diagnosed with Barrett's oesophagus (oesophageal/gastric control cohorts only) 7. Active infection, on immunosuppressive medications or antibiotic therapy within the last 8 weeks 8. Participants with co-morbidities preventing breath collection 9. Unable or unwilling to provide informed written consent 10. Pregnant participants
References
Publications (0)
Data not yet available
No reference posted for this study.