At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Exhaled breath sampling (other)
- How long the study runs
- Study runs about 36 months (dates as stated)
- About the drug or intervention
- Exhaled breath sampling — other: Participants will maintain a clear fluid diet for a minimum of 6 hours prior to breath collection.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years to 90 Years
- Who
- All
- Number of participants
- 518
- Started
- 2023-12-01
- Last checked
- 2025-04
Plain English Summary
What is this study?
- • Testing a new treatment for oesophageal squamous cell carcinoma
- • Clinical study - 518 participants
- • Oesophageal Squamous Cell Carcinoma (OSCC) is a cancer of the food pipe that affects around 2000 patients in the UK every year
Who can take part?
- • Ages 18 Years to 90 Years
- • Diagnosed with oesophageal squamous cell carcinoma
Where?
- • London - Imperial College Healthcare NHS Trust
- • Cottingham - Hull University Teaching Hospitals NHS Trust
- • Cardiff - Cardiff and Vale University Health Board
- • Cardiff - Velindre NHS Trust
- • +9 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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. 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.
More detail
In this prospective multicentre case-control study, the investigators will recruit a total of 518 patients. These will be divided into the following groups: 1. Cancer group (n=259): Patients with treatment naive, histopathology confirmed OSCC. 2. 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.
How this trial compares with your answers
Answer 2 more questions to improve match
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
- ✓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...
- ✓A normal upper gastrointestinal tract
- ✓Benign upper gastrointestinal disease
Who cannot take part
- ✗Participants with the following characteristics will not be eligible for inclusion in the study:
- ✗Received some form of treatment (drug treatment, radiotherapy, treatment that helps your immune system fight cancer, 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)
See the full criteria
Where Is This Study? (13 UK sites)
Imperial College Healthcare NHS Trust
London W12 0NN, United Kingdom
Hull University Teaching Hospitals NHS Trust
Cottingham, United Kingdom
Cardiff and Vale University Health Board
Cardiff, United Kingdom
Velindre NHS Trust
Cardiff, United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, United Kingdom
University Hospitals of Leicester NHS Foundation Trust
Leicester, United Kingdom
Liverpool University Hospitals NHS Foundation Trust
Liverpool, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom
Bedfordshire Hospitals NHS Foundation Trust
Luton, United Kingdom
Newcastle Upon Tyne Hospitals NHS Trust
Newcastle, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, United Kingdom
Oxford University Hospitals NHS Trust
Oxford, United Kingdom
Portsmouth Hospitals University NHS Trust
Portsmouth, United Kingdom
How to Get in Touch
Sameera Sharma, MBBS; MRCS
Sponsor contactCONTACT