RecruitingNCT06169163

Volatile Organic Compounds as Breath Biomarkers in Squamous Oesophageal Neoplasms


Sponsor

Imperial College London

Enrollment

518 participants

Start Date

Dec 1, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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

Interventions

OTHERExhaled breath sampling

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.


Locations(13)

Imperial College Healthcare NHS Trust

London, Greater London, United Kingdom

Hull University Teaching Hospitals NHS Trust

Cottingham, Hull, 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

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NCT06169163


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