Volatile Organic Compounds as Breath Biomarkers in Squamous Oesophageal Neoplasms
Imperial College London
518 participants
Dec 1, 2023
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
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
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)
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NCT06169163