Oesophageal Squamous Cell CarcinomaViSONNCT06169163
Volatile Organic Compounds as Breath Biomarkers in Squamous Oesophageal Neoplasms
An observational study of Oesophageal Squamous Cell Carcinoma and Oesophageal Cancer, run by Imperial College London at 13 sites in United Kingdom.
Trial summary
Oesophageal Squamous Cell Carcinoma (OSCC) is a cancer of the food pipe that affects around 2000 patients in the UK every year. It is often detected at an advanced stage, resulting in poor survival (5-year survival less than 20%). Early detection can improve survival (5-year survival >70%). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Oesophageal Squamous Cell Carcinoma, Oesophageal Cancer
- What is being tested?
- Exhaled breath sampling
- How many people
- 518 participants
- Where
- 13 sitesUnited Kingdom
- Study dates
- 1 Dec 2023to 31 Dec 2026
- Phase
- Observational
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with treatment naïve OSCC will be identified via the weekly multidisciplinary team (MDT) meetings (OSCC group). Patients undergoing an OGD for upper GI symptoms will be identified using the National Health Services (NHS) trust booking systems (Control group).
Inclusion Criteria: Participants with all the following characteristics will be eligible for inclusion in the study:
- Cancer cohort (n=259): Patients with treatment naïve, histopathology confirmed OSCC.
- Control cohort (n=259): Patients who have undergone or are undergoing an endoscopy (OGD) as part of their investigation for upper GI symptoms and are found to have either:
- A normal upper gastrointestinal tract
- Benign upper gastrointestinal disease
Exclusion Criteria: Participants with the following characteristics will not be eligible for inclusion in the study:
- Received some form of treatment (chemotherapy, radiotherapy, immunotherapy, endoscopic resection, or surgery) for OSCC
- History of another cancer in the last five years
- Non-squamous cell oesophageal cancer
- Barrett's oesophagus (with or without dysplasia)
- Previous oesophageal or gastric resection
- Unable to provide written consent or lack capacity.
- Pregnant women
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United Kingdom13 sites, 13 recruiting
- Not yet recruiting
Cardiff and Vale University Health Board
Cardiff
Tarig Abdelrahman
- Not yet recruiting
Velindre NHS Trust
Cardiff
Betsan Thomas
- Recruiting
Hull University Teaching Hospitals NHS Trust
Cottingham, Hull
Terence Lo
- Recruiting
University Hospitals Coventry and Warwickshire NHS Trust
Coventry
Martin Scott-Brown
- Recruiting
University Hospitals of Leicester NHS Foundation Trust
Leicester
Alex Boddy
- Not yet recruiting
Liverpool University Hospitals NHS Foundation Trust
Liverpool
Andrew Moore
- Recruiting
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool
Alia Alchawaf
- Recruiting
Imperial College Healthcare NHS Trust
London, Greater London, W12 0NN
George Hanna, PhD; FRCS, 02033122124, g.hanna@imperial.ac.uk
Sameera Sharma, MBBS; MRCS, 07576583519, ssharma@ic.ac.uk
- Not yet recruiting
Bedfordshire Hospitals NHS Foundation Trust
Luton
Periyathambi Jambulingam
- Recruiting
Newcastle Upon Tyne Hospitals NHS Trust
Newcastle
Shajahan Wahed
- Recruiting
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich
Bhaskar Kumar
- Recruiting
Oxford University Hospitals NHS Trust
Oxford
Somnath Mukherjee
- Not yet recruiting
Portsmouth Hospitals University NHS Trust
Portsmouth
Philip Pucher
About this study
Oesophageal Squamous Cell Carcinoma (OSCC) is a cancer of the food pipe that affects around 2000 patients in the UK every year. It is often detected at an advanced stage, resulting in poor survival (5-year survival less than 20%). Early detection can improve survival (5-year survival >70%). Therefore, early detection is vital to improving survival.
There are no national screening guidelines, and an endoscopy (A camera test to look at the food pipe) is the only available test to detect OSCC.
Read more
Early detection of OSCC is challenging for many reasons. Firstly, early disease symptoms are non-specific, which patients often overlook. Secondly, 'Alarm' symptoms such as weight loss, difficulty swallowing or vomiting blood are signs of advanced stage. Lastly, endoscopy is an invasive test with associated risks and significant discomfort.
The investigators propose to develop a breath test for patients with non-specific symptoms. Breath testing has the ideal characteristics for a triage test because it is non-invasive, simple to perform, cost-effective and highly acceptable to patients. The test is based on identifying volatile organic compounds (VOCs, small molecules) that are produced by the cancer and released in breath.
The breath test will be offered by General Practitioners (GPs) to patients with non-specific symptoms. Those who test positive will be referred for an urgent camera test, and those who test negative can be reassured.
Read the detailed description
In this prospective multicentre case-control study, the investigators will recruit a total of 518 patients. These will be divided into the following groups:
- Cancer group (n=259): Patients with treatment naive, histopathology confirmed OSCC.
- Control group (n=259): Patients who have undergone or are undergoing an upper gastrointestinal (GI) endoscopy as part of their investigation for upper GI symptoms and are found to have either - (i) A normal upper GI tract or (ii) Benign upper GI disease.
Eligible and willing participants will be asked to provide two breath samples by exhaling into single-use breath collection bags. Using a custom designed gas sampling pump, the breath VOCs will be transferred onto thermal desorption (TD) tubes at a controlled flow rate. When the participants' breath sampling is complete, room air (Blank) samples will be taken onto additional TD tubes using the same process.
Once collected, the TD tubes will be transported to Imperial College London (The Hanna lab), where they will be analysed.
- Being tested
- Exhaled breath sampling
- Keywords
- Breath biomarker, Early detection, Oesophageal cancer, Oesophageal squamous cell cancer, Volatile organic compounds
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exhaled breath samplingOther
Participants will maintain a clear fluid diet for a minimum of 6 hours prior to breath collection. Participants will be asked to provide a breath sample by exhaling into single-use breath collection bags. Using a custom designed gas sampling pump, the breath VOCs will be transferred onto TD tubes at a controlled flow rate. This breath sampling procedure will be repeated once. When the participants' breath sampling is complete, room air (Blank) samples must be taken onto additional TD tubes using the same procedure. The TD tubes will be sealed with long-term storage caps using the CapLok Tool.
| Study group | Role | What they receive |
|---|---|---|
| OSCC group | Patients with histopathology confirmed, treatment naive OSCC Receives: Other: Exhaled breath sampling | |
| Non-cancer controls | Patients who are undergoing an endoscopy for non-specific upper gastrointestinal (GI) symptoms and are shown to have either:
1. A healthy upper GI tract
2. Benign upper gastrointestinal disease Receives: Other: Exhaled breath sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop a breath test for detection of OSCC
The investigators hypothesise that breath VOCs in OSCC are unique and different to those in non-cancer patients. Replicate breath samples will be analysed by two independent assays using different Thermal Desorption - Gas Chromatography - Time of Flight Mass Spectrometry (TD-GC-TOF-MS) instruments. One assay will use a mid-polar, and the other a polar column stationary phase for optimal determination of VOC chemical classes. The samples will then be recollected and analysed by two-dimensional (2D) TD-GC-TOF-MS for robust VOC identification. Confirming the identity of the top VOCs driving the model will provide chemical validation. Data obtained will be used to refine the model using molecular network analysis. Statistical methods will estimate the probability of OSCC as a function of measured VOCs. Calibrations and method validation will be used to assess and correct for discrimination.
Measured: 36 months
Secondary outcomes (1)
To evaluate the effects of known confounding variables on the target VOCs in OSCC
To develop this clinical triage test, the investigators will use logistic regression modelling. They will assess the linearity of relationships between OSCC risk and continuous variables and explore categorical variables and two-way interactions. Inclusion of patient characteristics (e.g., age, gender, alcohol use and smoking), clinical variables (e.g., symptoms) and VOCs in the model will be determined using a combination of statistical significance (Wald p<0.05), size of the model coefficients and clinical opinion, drawing on contemporary methods for clinical prediction rules.
The investigators will use model reduction techniques such as the LASSO (least absolute shrinkage and selection operator) or Harrell's step-down approach to prevent over-fitting. They will also assess optimism. If there is missing data, the investigators will apply multiple imputation techniques.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start1 Dec 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oesophageal Squamous Cell CarcinomaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 518 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, Hull University Teaching Hospitals NHS Trust, Norfolk and Norwich University Hospitals NHS Foundation Trust, University Hospitals Coventry and Warwickshire NHS Trust, Oxford University Hospitals NHS Trust, Velindre NHS Trust, Cardiff and Vale University Health Board, Newcastle-upon-Tyne Hospitals NHS Trust, Liverpool University Hospitals NHS Foundation Trust, Bedfordshire Hospitals NHS Foundation Trust, University Hospitals, Leicester, The Clatterbridge Cancer Centre NHS Foundation Trust, Portsmouth Hospitals NHS Trust, University Hospital Plymouth NHS Trust, NHS Tayside, NHS Highlands, The Christie NHS Foundation Trust, North Cumbria University Hospitals NHS Trust, Maidstone & Tunbridge Wells NHS Trust, University Hospitals of Derby and Burton NHS Foundation Trust, Bradford Teaching Hospitals NHS Foundation Trust, East and North Hertfordshire NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169163
- Sponsor's protocol ID
- 23SM8534
- Acronym
- ViSON
- Status last verified
- Apr 2025
- First submitted
- 24 Nov 2023
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sharma S, Murray J, Parker A, Jamel S, Antonowicz S, Phillips A, Bailey E, Fox L, Plant C, Converso V, Ellis JK, Mukherjee S, Kumar B, Lo T, Wahed S, Alchawaf A, Moore AR, Boddy A, Scott-Brown M, Thomas B, Abdelrahman T, Pucher PH, El-Sharkawy A, Forner S, Wayman J, Elshaer A, Chan D, Mcnally S, Petty R, Patil P, Bhuva N, Periyathambi J, Bhatt L, Vohra R, Sharples L, Hanna GB; ViSON Collaborators. Development of a clinical prediction model using volatile organic compounds as breath biomarkers in squamous oesophageal neoplasms: ViSON, protocol for a multicentre case-control study in UK NHS hospitals. BMJ Open. 2026 Sep 28;16(9):e112493. doi: 10.1136/bmjopen-2025-112493.
PubMed 42805665