Breath test to help detect gastrointestinal cancers early

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 develops and tests a non-invasive breath test that analyzes volatile organic compounds in exhaled air to identify patients at risk of gastrointestinal cancers. It targets cancers of the oesophagus, stomach, pancreas, liver, and colorectum, aiming to flag high-risk individuals who should receive prompt diagnostic investigation. Participants include adults with non-specific abdominal symptoms, evaluated across multiple arms matching their suspected cancer type and appropriate control groups. The study seeks to streamline referral pathways and reduce delays to endoscopy or imaging by identifying VOC patterns associated with cancer. Results will inform whether breath VOC analysis can aid early detection and triage in clinical practice.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Adult participants ≥ 18 years old who meet at least one of the following criteria

Colorectal arm:

1. Cancer: Histologically-confirmed CRC\*
2. Control: Non-specific abdominal symptoms with normal or benign colonoscopy findings

Pancreatic arm:

1. Cancer: Histologically-confirmed PDAC\*
2. Control: Non-specific abdominal symptoms with a radiologically-normal pancreas

Oesophagogastric arm:

1. Cancer: Histologically-confirmed OGC\*
2. Control: Non-specific abdominal symptoms with normal or benign upper gastrointestinal endoscopy findings

Oesophageal squamous arm:

1. Cancer: Histologically-confirmed OSCC\*
2. Control: Non-specific abdominal symptoms with normal or benign upper gastrointestinal endoscopy findings

Liver arm:

1. Cancer: Histologically- or radiologically-confirmed HCC or CCC\*
2. Control: Non-specific abdominal symptoms with a radiologically-normal liver

   * Patients with suspected cancer (e.g. based on imaging) but who do not have histological confirmation prior to participating in the study may still be recruited and followed up to determine whether or not a diagnosis of cancer was subsequently confirmed.

Exclusion Criteria:

* Patients who have already received chemotherapy, radiotherapy or surgery for their cancer
* History of another cancer (other than non-melanoma skin cancers) within three years
* Participants with co-morbidities preventing breath collection
* Unable or unwilling to provide informed consent
* (For Oesophagogastric arm only): Allergies to any of the constituents of the nutrient drink including glucose, glycerol, iron sulphate, Maltodextrin (Corn, Potato), Xanthan Gum, Potassium Chloride, tyrosine, phenylalanine, and glutamic acid
* (For Colorectal arm only): Participants receiving bowel prep in the previous 7 days

Where it's running

• Imperial College Healthcare NHS Trust
  London, United Kingdom Recruiting
• Maidstone and Tunbridge Wells NHS Trust
  Maidstone, Kent, United Kingdom Not yet recruiting
• Liverpool University Hospitals NHS Foundation Trust
  Liverpool, Merseyside, United Kingdom Not yet recruiting
• NHS Greater Glasgow and Clyde
  Glasgow, United Kingdom Not yet recruiting
• The Clatterbridge Cancer Centre NHS Foundation Trust
  Liverpool, United Kingdom Not yet recruiting
• Royal Free London NHS Foundation Trust
  London, United Kingdom Not yet recruiting

Study contacts

• Principal investigator: George Hanna, MBBS; PhD; FRSC — Imperial College London
• Study coordinator: Jessie S McClymont, Medical Biosciences BSc
• Email: brave-study@imperial.ac.uk
• Phone: +44 7434937543

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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.