Volatile Organic CompoundsNCT05412758
Augmented Response of Volatile Biomarkers in Assessment of Oesophagogastric Cancer (AROMA 1 / BIORESOURCE)
A study testing Oral Stimulant Drink in people with Volatile Organic Compounds and Microbiome, run by Imperial College London at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Volatile Organic Compounds, Microbiome, Microbioata
- What is being tested?
- Oral Stimulant Drink
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 648 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Feb 2022to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College NHS Foundation Trust
London, W12 0HS
George Hanna, PhD, FRCS, 02033122124, g.hanna@imperial.ac.uk
Piers Boshier, PhD, FRCS, 02033122124, prb03@ic.ac.uk
About this study
Official title: Augmented Response of Volatile Biomarkers in Assessment of Oesophagogastric Cancer
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.
Read the detailed description
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.
- Conditions
- Volatile Organic Compounds, Microbiome, Microbioata, Breath Analysis, Oesophageal Cancer, Gastric Cancer
- Being tested
- Oral Stimulant Drink
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Stimulant DrinkDietary supplement
Also called Oral Nutrient Drink
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. Following consumption of the drink, serial breath tests will be performed to determine varying levels of VOC production in breath
| Study group | Role | What they receive |
|---|---|---|
| Oesophageal/GOJ cancer | Experimental | 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. Receives: Dietary Supplement: Oral Stimulant Drink |
| Gastric cancer | Experimental | 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. Receives: Dietary Supplement: Oral Stimulant Drink |
| Control/ normal patients with upper gastrointestinal symptoms | Experimental | AROMA 1: 216 control subjects will be recruited to undertake an augmented breath test.
BIORESOURCE: 150 control subjects will be recruited for biosample collection at the time of their routine endoscopy procedure. Receives: Dietary Supplement: Oral Stimulant Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of an oral nutrient drink to stimulate the production of volatile organic compounds detected in the breath.
Efficacy of the oral stimulant drink will be measured by comparing the relative abundance of certain volatile organic compounds (measured in ppt) detected in the breath. Breath analysis will be performed with the help of Gas Chromatography- Mass Spectrometry (GC-MS)
Measured: 18 months
Secondary outcomes (5)
Volatile metabolites present in breath of subjects with oesophagogastric cancer and controls
GC-MS will be used to determine the presence of certain cancer associated volatile organic compounds in breath
Measured: 18 months
Volatile metabolites present in headspace of the urine of subjects with oesophagogastric cancer and controls
Headspace sampling techniques will be used for headspace collection from urine samples. GC-MS will be used to determine the presence of certain cancer associated volatile organic compounds within the headspace of urine.
Measured: 18 months
Determination of bacterial species and cancer associated volatile compound production from saliva samples of subjects with oesophagogastric cancer.
Bacterial species will be determined using sequencing techniques such as 16s or whole genome sequencing. Bacteria within the saliva samples will be cultured and species isolated. Once isolated, cancer associated species will be re-cultured within a controlled environment. Headspace and media sampling will be performed to determine the volatile metabolites present using GC-MS and LC-MS techniques
Measured: 18 months
Determination of bacterial species and cancer associated volatile compound production from tissue samples of subjects with oesophagogastric cancer
Bacterial species will be determined using sequencing techniques such as 16s or whole genome sequencing. Tissue and bacteria from biopsies will be separated. Bacteria derived from tissue samples will be cultured and species isolated. Once isolated, cancer associated species will be re-cultured within a controlled environment. Headspace and media sampling will be performed to determine the volatile metabolites present using GC-MS and LC-MS techniques
Measured: 18 months
Determination of bacterial species and cancer associated volatile compound production from gastric contents of subjects with oesophagogastric cancer
Bacterial species will be determined using sequencing techniques such as 16s or whole genome sequencing. Bacteria from gastric content samples will be separated. Bacteria derived from gastric juices will be cultured and species isolated. Once isolated, cancer associated species will be re-cultured within a controlled environment. Headspace and media sampling will be performed to determine the volatile metabolites present using GC-MS and LC-MS techniques
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start28 Feb 2022
- Primary completionJul 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Volatile Organic CompoundsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- There are two arms to this study; AROMA 1 and BIORESOURCE. It is the AROMA 1 arm of the study that involves an intervention. 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 the first baseline breath sample at 0 minutes is collected, subjects will then be asked to consume a standard nutrient drink. Further breath samples will be collected at 15 minutes after consumption of the drink.
- Masking
- None (open label)
- Enrolment
- 648 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, Newcastle-upon-Tyne Hospitals NHS Trust, University Hospital Birmingham NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust, Norfolk and Norwich University Hospitals NHS Foundation Trust, Nottingham University Hospitals NHS Trust, University Hospital Plymouth NHS Trust, Royal Surrey County Hospital NHS Foundation Trust, University Hospitals Coventry and Warwickshire NHS Trust, Guy's and St Thomas' NHS Foundation Trust, Portsmouth Hospitals NHS Trust, Barking, Havering and Redbridge University Hospitals NHS Trust, Northern Care Alliance NHS Foundation Trust, Brighton and Sussex University Hospitals NHS Trust, University College London Hospitals, Cardiff and Vale University Health Board, NHS Lothian, NHS Tayside, York Teaching Hospitals NHS Foundation Trust, The Harley Street Clinic
- Responsible party
- Sponsor
- Investigators
- George Hanna, PhD, FRCS, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412758
- Sponsor's protocol ID
- 21HH7100
- Status last verified
- Jan 2025
- First submitted
- 1 Apr 2022
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Response of Volatile Biomarkers in Assessment of Oesophagogastric Cancer
- ClinicalTrials.gov ID
- NCT05412758
- Acronym / sponsor ID
- 21HH7100
- Conditions
- Volatile Organic Compounds, Microbiome, Microbioata, Breath Analysis, Oesophageal Cancer, Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 648 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, Newcastle-upon-Tyne Hospitals NHS Trust, University Hospital Birmingham NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust, Norfolk and Norwich University Hospitals NHS Foundation Trust, Nottingham University Hospitals NHS Trust, University Hospital Plymouth NHS Trust, Royal Surrey County Hospital NHS Foundation Trust, University Hospitals Coventry and Warwickshire NHS Trust, Guy's and St Thomas' NHS Foundation Trust, Portsmouth Hospitals NHS Trust, Barking, Havering and Redbridge University Hospitals NHS Trust, Northern Care Alliance NHS Foundation Trust, Brighton and Sussex University Hospitals NHS Trust, University College London Hospitals, Cardiff and Vale University Health Board, NHS Lothian, NHS Tayside, York Teaching Hospitals NHS Foundation Trust, The Harley Street Clinic
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- There are two arms to this study; AROMA 1 and BIORESOURCE. It is the AROMA 1 arm of the study that involves an intervention. 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 the first baseline breath sample at 0 minutes is collected, subjects will then be asked to consume a standard nutrient drink. Further breath samples will be collected at 15 minutes after consumption of the drink.
| Arm | Type | Receives |
|---|---|---|
| Oesophageal/GOJ cancer | Experimental | Dietary Supplement: Oral Stimulant DrinkAROMA 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. |
| Gastric cancer | Experimental | Dietary Supplement: Oral Stimulant DrinkAROMA 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. |
| Control/ normal patients with upper gastrointestinal symptoms | Experimental | Dietary Supplement: Oral Stimulant DrinkAROMA 1: 216 control subjects will be recruited to undertake an augmented breath test. BIORESOURCE: 150 control subjects will be recruited for biosample collection at the time of their routine endoscopy procedure. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Stimulant DrinkAlso: Oral Nutrient DrinkFor 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. Following consumption of the drink, serial breath tests will be performed to determine varying levels of VOC production in breath | Dietary supplement | Control/ normal patients with upper gastrointestinal symptoms, Gastric cancer, Oesophageal/GOJ cancer |
Primary outcome
Efficacy of an oral nutrient drink to stimulate the production of volatile organic compounds detected in the breath.
Time frame: 18 months
Efficacy of the oral stimulant drink will be measured by comparing the relative abundance of certain volatile organic compounds (measured in ppt) detected in the breath. Breath analysis will be performed with the help of Gas Chromatography- Mass Spectrometry (GC-MS)
5 secondary outcomes
Volatile metabolites present in breath of subjects with oesophagogastric cancer and controls
Time frame: 18 months
Volatile metabolites present in headspace of the urine of subjects with oesophagogastric cancer and controls
Time frame: 18 months
Determination of bacterial species and cancer associated volatile compound production from saliva samples of subjects with oesophagogastric cancer.
Time frame: 18 months
Determination of bacterial species and cancer associated volatile compound production from tissue samples of subjects with oesophagogastric cancer
Time frame: 18 months
Determination of bacterial species and cancer associated volatile compound production from gastric contents of subjects with oesophagogastric cancer
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
George Hanna, PhD, FRCS principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Stimulant Drink in people with Volatile Organic Compounds and Microbiome, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayushi Pabari, BSc, MSc (02075948847, aroma@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of an oral nutrient drink to stimulate the production of volatile organic compounds detected in the breath. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.