At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Oral Stimulant Drink (supplement)
- How long the study runs
- Study runs about 44 months (dates as stated)
- About the drug or intervention
- Oral Stimulant Drink — supplement: For the AROMA 1 study patients will be requested to consume a nutrient drink (approximately 200 ml) that includes natural ingredients found within a typical human diet.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 90 Years
- Who
- All
- Number of participants
- 648
- Started
- 2022-02-28
- Last checked
- 2025-01
Plain English Summary
What is this study?
- • Testing a new treatment for volatile organic compounds
- • NA - 648 participants
- • Cancer of the stomach and oesophagus is among the world's top five cancers
Who can take part?
- • Ages 18 Years to 90 Years
- • Diagnosed with volatile organic compounds
Where?
- • London - Imperial College NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
More detail
AROMA 1: A total of 648 patients will be recruited for development of an augmented breath test to detect oesophageal and gastric cancer at early stages of disease. Three groups, each containing 216 patients, will be recruited: (i) oesophageal cancer (ii) gastric cancer and (iii) control/normal patients with upper gastrointestinal symptoms. After a baseline breath sample is collected, subjects will then be asked to consume a standard nutrient drink. Further breath samples will be collected at 0 and 15 minutes after consumption of the drink. Breath samples will be stored on thermal desportion tubes before being transfered to a central laboratory for analysis. Breath samples will be analysed in accordance with existing quality-controlled processes. A combined approach of chromatographic- and real time- mass spectrometric techniques will be applied for VOC profiling. BIORESOURCE: Samples from 335 patients will be collected in order to establish a biobank for multi-omic analyses. Three groups, each containing 75 patients, will be recruited: (i) oesophageal adenocarcinoma; (ii) gastric adenocarcinoma and (iii) oesophageal controls - benign conditions/normal gastrointestinal tract with upper gastrointestinal symptoms (iv) gastric controls - benign conditions/normal gastrointestinal tract with upper gastrointestinal symptoms. The following biosamples will be collected: breath, urine, saliva, blood, tissue and gastric contents. Collected samples will be utilised in a wide range of studies to investigate the mechanisms of VOC production in cancer. The following analyses will be performed: volatalomics, metabonomics/lipidomics, microbiome analysis, transcriptomics and cell culture experiments.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 90 Years
- Who can join: All genders
What the study is looking for
- ✓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...
- ✓AROMA 1
Who cannot take part
- ✗Patients with the following characteristics will not be eligible for inclusion in this study:
- ✗Oesophageal squamous cell carcinoma
- ✗Previous oesophageal and gastric resection
- ✗Received before surgery drug treatment for oesophageal or gastric cancer
- ✗History of another cancer within three years
See the full criteria
Where Is This Study? (1 UK site)
Imperial College NHS Foundation Trust
London W12 0HS, United Kingdom
How to Get in Touch
Ayushi Pabari, BSc, MSc
Sponsor contactCONTACT