NCT05412758Recruiting
Augmented Response of Volatile Biomarkers in Assessment of Oesophagogastric Cancer (AROMA 1 / BIORESOURCE)
Augmented Response of Volatile Biomarkers in Assessment of Oesophagogastric Cancer
Source: ClinicalTrials.gov · Last updated 31 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 648 (estimated)
- First submitted
- 1 Apr 2022
- Start date
- 28 Feb 2022
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- Imperial College London
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05412758
What you commit to
- Study type: Interventional
- Planned participants: 648
- From 28 Feb 2022 to the primary completion date, 31 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- AROMA 1 Inclusion Criteria:
- Aged 18-90years
- Oesophageal/gastric cancer cohort: participants with biopsy proven adenocarcinoma who are treatment naïve
- 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:
- Oesophageal squamous cell carcinoma
- Previous oesophageal and gastric resection
- Received neoadjuvant chemotherapy for oesophageal or gastric cancer
- History of another cancer within three years
- Any form of oesophageal dysplasia (control cohort only)
- Previously diagnosed with Barrett's oesophagus (control cohort only)
- Active infection, on immunosuppressive medications or antibiotic therapy within the last 8 weeks
- Participants with co-morbidities preventing breath collection
- 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
- Pregnant participants
- BIORESOURCE inclusion criteria:
- Aged 18- 90years
- Oesophageal/gastric cancer cohort: participants with biopsy proven adenocarcinoma who are treatment naïve
- Oesophageal/gastric control cohort: participants with normal or benign upper gastrointestinal disease determined on: • Planned endoscopy
- BIORESOURCE exclusion criteria:
- Oesophageal squamous cell carcinoma
- Previous oesophageal and gastric resection
- Received neoadjuvant chemotherapy for oesophageal or gastric cancer
- History of another cancer within five years
- Any form of oesophageal dysplasia (oesophageal/gastric control cohorts only)
- Previously diagnosed with Barrett's oesophagus (oesophageal/gastric control cohorts only)
- Active infection, on immunosuppressive medications or antibiotic therapy within the last 8 weeks
- Participants with co-morbidities preventing breath collection
- Unable or unwilling to provide informed written consent
- Pregnant participants
Age in the registry: 18 years to 90 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Imperial College NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.