Fact CheckerSign in

NCT06169163Recruiting

Volatile Organic Compounds as Breath Biomarkers in Squamous Oesophageal Neoplasms

Source: ClinicalTrials.gov · Last updated 2 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
518 (estimated)
First submitted
24 Nov 2023
Start date
1 Dec 2023
Primary completion date
30 Nov 2026
Lead sponsor
Imperial College London
NCT number
NCT06169163

What you commit to

  • Study type: Observational
  • Planned participants: 518
  • From 1 Dec 2023 to the primary completion date, 30 Nov 2026
  • 13 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Received some form of treatment (chemotherapy, radiotherapy, immunotherapy, endoscopic resection, or surgery) for OSCC
  • Previous oesophageal or gastric resection

Other illness

  • History of another cancer in the last five years
  • Non-squamous cell oesophageal cancer

Other

  • Barrett's oesophagus (with or without dysplasia)
  • Unable to provide written consent or lack capacity.
  • Pregnant women

Who the study is looking for

  • 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

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cardiff and Vale University Health Board
Coordinator of this site? Confirm its status
CardiffUnited KingdomNot yet recruiting
Velindre NHS Trust
Coordinator of this site? Confirm its status
CardiffUnited KingdomNot yet recruiting
Hull University Teaching Hospitals NHS Trust
Coordinator of this site? Confirm its status
CottinghamUnited KingdomRecruiting
University Hospitals Coventry and Warwickshire NHS Trust
Coordinator of this site? Confirm its status
CoventryUnited KingdomRecruiting
University Hospitals of Leicester NHS Foundation Trust
Coordinator of this site? Confirm its status
LeicesterUnited KingdomRecruiting
The Clatterbridge Cancer Centre NHS Foundation Trust
Coordinator of this site? Confirm its status
LiverpoolUnited KingdomRecruiting
Liverpool University Hospitals NHS Foundation Trust
Coordinator of this site? Confirm its status
LiverpoolUnited KingdomNot yet recruiting
Imperial College Healthcare NHS Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Bedfordshire Hospitals NHS Foundation Trust
Coordinator of this site? Confirm its status
LutonUnited KingdomNot yet recruiting
Newcastle Upon Tyne Hospitals NHS Trust
Coordinator of this site? Confirm its status
NewcastleUnited KingdomRecruiting
Norfolk and Norwich University Hospitals NHS Foundation Trust
Coordinator of this site? Confirm its status
NorwichUnited KingdomRecruiting
Oxford University Hospitals NHS Trust
Coordinator of this site? Confirm its status
OxfordUnited KingdomRecruiting
Portsmouth Hospitals University NHS Trust
Coordinator of this site? Confirm its status
PortsmouthUnited KingdomNot yet recruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.