Breath Research Narrow Validation for Gastrointestinal Cancer Detection

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Conditions studied: Oesophageal Squamous Cell Carcinoma, Oesophageal Adenocarcinoma, Gastric Adenocarcinoma, Pancreatic Ductal Adenocarcinoma (PDAC), Cholangiocarcinoma, Hepatocellular Carcinoma (HCC), Colorectal Adenocarcinoma

In brief

The investigators of this study are developing a simple breath test to help detect gastrointestinal (gut) cancers earlier, including cancers of the oesophagus (food pipe), stomach, pancreas, liver and bowel. These cancers often cause non-specific symptoms that are similar to benign conditions, making early diagnosis difficult. Delays between the onset of symptoms and referral for a diagnostic test such as an endoscopy or a scan, can allow the cancer to progress. The breath test detects small molecules called volatile organic compounds (VOCs) that are released in exhaled breath. Some of these VOCs are strongly associated with these cancers and may help identify high-risk patients who require urgent investigation. In practice, patients who come to their GP with concerning symptoms will be offered the breath test. If the test is positive, patients can be referred promptly for a diagnostic test, while those with a negative result can be reassured and offered re-testing if symptoms persist. Earlier diagnosis could improve access to curative treatment while reducing unnecessary invasive investigations. Previous studies have identified a panel of VOCs that appear to distinguish patients with gastrointestinal cancers from those without cancer. This study aims to confirm these findings in a new group of participants to determine whether the same biomarkers can be reliably identified. Participants will provide a breath sample, usually before a hospital procedure they are already scheduled to undergo, and complete a short questionnaire about their medical history and medications. Some participants will also be asked to drink a nutritional supplement before providing a second breath sample. The results will help determine whether the breath test is reliable enough for further clinical evaluation

Key facts

Study ID

NCT07714538

Run by

Imperial College London

People needed

1000

Starts

2026-07-20

Expected to finish

2028-08-02

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult participants ≥ 18 years old who meet at least one of the following criteria
• Colorectal arm:
• Cancer: Histologically-confirmed CRC*
• Control: Non-specific abdominal symptoms with normal or benign colonoscopy findings
• Pancreatic arm:
• Cancer: Histologically-confirmed PDAC*
• Control: Non-specific abdominal symptoms with a radiologically-normal pancreas
• Oesophagogastric arm:
• Cancer: Histologically-confirmed OGC*
• Control: Non-specific abdominal symptoms with normal or benign upper gastrointestinal endoscopy findings
• Oesophageal squamous arm:
• Cancer: Histologically-confirmed OSCC*
• Control: Non-specific abdominal symptoms with normal or benign upper gastrointestinal endoscopy findings
• Liver arm:
• Cancer: Histologically- or radiologically-confirmed HCC or CCC*
• 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.

You may not qualify if…

• 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 is running

• Maidstone and Tunbridge Wells NHS Trust — Maidstone, Kent, United Kingdom
• Liverpool University Hospitals NHS Foundation Trust — Liverpool, Merseyside, United Kingdom
• NHS Greater Glasgow and Clyde — Glasgow, United Kingdom
• The Clatterbridge Cancer Centre NHS Foundation Trust — Liverpool, United Kingdom
• Royal Free London NHS Foundation Trust — London, United Kingdom
• Imperial College Healthcare NHS Trust — London, United Kingdom

Full record on ClinicalTrials.gov

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