Volatile Organic Compounds as Breath Biomarkers in Squamous Oesophageal Neoplasms

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Other
Study Type: Observational
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%). 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Cardiff and Vale University Health Board
NOT_YET_RECRUITING
Cardiff
Velindre NHS Trust
NOT_YET_RECRUITING
Cardiff
Hull University Teaching Hospitals NHS Trust
RECRUITING
Cottingham
University Hospitals Coventry and Warwickshire NHS Trust
RECRUITING
Coventry
University Hospitals of Leicester NHS Foundation Trust
RECRUITING
Leicester
Liverpool University Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Liverpool
The Clatterbridge Cancer Centre NHS Foundation Trust
RECRUITING
Liverpool
Imperial College Healthcare NHS Trust
RECRUITING
London
Bedfordshire Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Luton
Newcastle Upon Tyne Hospitals NHS Trust
RECRUITING
Newcastle
Norfolk and Norwich University Hospitals NHS Foundation Trust
RECRUITING
Norwich
Oxford University Hospitals NHS Trust
RECRUITING
Oxford
Portsmouth Hospitals University NHS Trust
NOT_YET_RECRUITING
Portsmouth
Contact Information
Primary
Sameera Sharma, MBBS; MRCS
vison@imperial.ac.uk
07576583519
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 518
Treatments
OSCC group
Patients with histopathology confirmed, treatment naive OSCC
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
Related Therapeutic Areas
Sponsors
Collaborators: University Hospitals Coventry and Warwickshire NHS Trust, The Christie NHS Foundation Trust, Velindre NHS Trust, Newcastle-upon-Tyne Hospitals NHS Trust, Norfolk and Norwich University Hospitals NHS Foundation Trust, University Hospitals of Derby and Burton NHS Foundation Trust, North Cumbria University Hospitals NHS Trust, Portsmouth Hospitals NHS Trust, NHS Tayside, Oxford University Hospitals NHS Trust, Maidstone & Tunbridge Wells NHS Trust, Hull University Teaching Hospitals NHS Trust, Imperial College Healthcare NHS Trust, East and North Hertfordshire NHS Trust, Liverpool University Hospitals NHS Foundation Trust, The Clatterbridge Cancer Centre NHS Foundation Trust, Bedfordshire Hospitals NHS Foundation Trust, Cardiff and Vale University Health Board, Bradford Teaching Hospitals NHS Foundation Trust, University Hospital Plymouth NHS Trust, University Hospitals, Leicester, NHS Highlands
Leads: Imperial College London

This content was sourced from clinicaltrials.gov