Breath test for detecting oesophageal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to develop a breath test that can detect Oesophageal Squamous Cell Carcinoma (OSCC) in patients with non-specific symptoms. A total of 518 participants will be recruited, divided into a cancer group with confirmed OSCC and a control group with normal or benign upper gastrointestinal conditions. Participants will provide breath samples, which will be analyzed for volatile organic compounds (VOCs) at Imperial College London. The goal is to create a non-invasive early detection method for OSCC, improving survival rates.

Why it matters

Who can join: the full rules

Inclusion Criteria: Participants with all the following characteristics will be eligible for inclusion in the study:

1. Cancer cohort (n=259): Patients with treatment naïve, histopathology confirmed OSCC.
2. 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 Criteria: Participants with the following characteristics will not be eligible for inclusion in the study:

1. Received some form of treatment (chemotherapy, radiotherapy, immunotherapy, endoscopic resection, or surgery) for OSCC
2. History of another cancer in the last five years
3. Non-squamous cell oesophageal cancer
4. Barrett's oesophagus (with or without dysplasia)
5. Previous oesophageal or gastric resection
6. Unable to provide written consent or lack capacity.
7. Pregnant women

Where it's running

• Imperial College Healthcare NHS Trust
  London, Greater London, United Kingdom Recruiting
• Hull University Teaching Hospitals NHS Trust
  Cottingham, Hull, United Kingdom Recruiting
• University Hospitals Coventry and Warwickshire NHS Trust
  Coventry, United Kingdom Recruiting
• University Hospitals of Leicester NHS Foundation Trust
  Leicester, United Kingdom Recruiting
• The Clatterbridge Cancer Centre NHS Foundation Trust
  Liverpool, United Kingdom Recruiting
• Newcastle Upon Tyne Hospitals NHS Trust
  Newcastle, United Kingdom Recruiting

Study contacts

• Study coordinator: Sameera Sharma, MBBS; MRCS
• Email: vison@imperial.ac.uk
• Phone: 07576583519

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.