Volatile Organic Compounds as Breath Biomarkers in Squamous Oesophageal Neoplasms — ViSON  

Oesophageal Cancer Clinical Trial

Official title: Volatile Organic Compounds as Breath Biomarkers in Squamous Oesophageal Neoplasms

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma
• Neoplasms
• Oesophageal Cancer
• Oesophageal Squamous Cell Carcinoma

• NCT number: NCT06169163
• Study type: Observational
• Source: Imperial College London
• Contact: Sameera Sharma, MBBS; MRCS
• Phone: 07576583519
• Email: vison@imperial.ac.uk
• Status: Recruiting
• Start date: December 1, 2023
• Completion date: December 31, 2026