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Breath test to help detect cancers of the digestive system

Tests a breath sample for signs of digestive system cancers in adults.

Key facts

Who runs it
Imperial College London
Where
Glasgow, Liverpool, London, and Maidstone, United KingdomSee the 6 sites
Trial code
Registry title
Breath Research Narrow Validation for Gastrointestinal Cancer Detection
Status
Recruiting
People taking part
1,000 people, planned
Started
26 Jul 2026
Expected to end
2 Feb 2029
Type of study
Observational, 5 groups
Record updated
22 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a gut cancer, and adults without cancer who have vague belly symptoms. Everyone gives a breath sample to test a breath test for cancer.

Age
18 years or older
Sex
All sexes can join
Disease stage
Gut cancer confirmed by tissue test (colon or rectum, pancreas, oesophagus, stomach), or liver cancer confirmed by tissue test or scan. People without cancer need vague belly symptoms and normal or benign test findings.
Earlier treatment
People with cancer cannot join if they already had chemotherapy, radiotherapy or surgery for the cancer.

Main reasons for not taking part

  • Already had chemotherapy, radiotherapy or surgery for the cancer
  • Another cancer in the last three years (skin cancers other than melanoma do not count)
  • Health problems that stop breath collection
  • Unable or unwilling to give informed consent
  • Allergy to the nutrient drink (oesophagus and stomach group only)

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Patients who have already received chemotherapy, radiotherapy or surgery for their cancer
  • (For Colorectal arm only): Participants receiving bowel prep in the previous 7 days
  • History of another cancer (other than non-melanoma skin cancers) within three years
  • (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
  • Participants with co-morbidities preventing breath collection
  • Unable or unwilling to provide informed consent

Where in United Kingdom

  • NHS Greater Glasgow and ClydeGlasgow, United KingdomContact: Gary Nicholson, MBBS; FRCSNot yet recruiting
  • Liverpool University Hospitals NHS Foundation TrustLiverpool, United KingdomContact: Andrew Moore, MBBS; MRCPNot yet recruiting
  • The Clatterbridge Cancer Centre NHS Foundation TrustLiverpool, United KingdomContact: Alia Alchawaf, MBBS; MRCPNot yet recruiting
  • Imperial College Healthcare NHS TrustLondon, United KingdomContact: Jessie S McClymont, BScTaking people
  • Royal Free London NHS Foundation TrustLondon, United KingdomContact: Georgia Woodfield, MBBS; MRCPNot yet recruiting
  • Maidstone and Tunbridge Wells NHS TrustMaidstone, United KingdomContact: Samantha Forner, MBBS; MRCPNot yet recruiting

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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

The 5 groups in the trial

  • Oesophagogastric Arm

    Cases will be patients with histology-confirmed, treatment naïve oesophageal (OAC) or gastric adenocarcinoma (GAC) and controls will be patients who have a normal upper GI tract or benign condition as diagnosed on the reference test (upper GI endoscopy). All eligible patients will be invited to participate. Participants will attend a one off research visit, after having fasted for 6 hours (water permitted) and sign a consent form. They will rinse their mouth with water, provide a baseline breath sample and consume an oral stimulant drink (a nutrient supplement). A further breath sample will be collected after 15 minutes, and an additional environment sample will also be collected. Participants will answer questions about their medical and drug history.

  • Oesophageal SCC Arm

    Cases will be patients with histology-confirmed, treatment naive Oesophageal Squamous Cell Carcinoma (OSCC) and controls will be patients who have a normal upper GI tract or benign condition as diagnosed on the reference test (upper GI endoscopy). All eligible patients will be invited to participate. Participants will attend a one-off research visit, after having fasted for 6 hours (water permitted) and sign a consent form. They will rinse their mouth with water and provide a breath sample. An additional environment sample will also be collected. Participants will answer questions about their medical and drug history.

  • Pancreatic Arm

    Cases will be patients with histology-confirmed, treatment naïve pancreatic ductal adenocarcinoma (PDAC) and controls will be patients with non-specific abdominal symptoms and a radiologically-normal pancreas as diagnosed on the reference test (ultrasound, MRI, CT, PET-CT and endoscopic ultrasound). All eligible patients will be invited to participate. Participants will attend a one-off research visit, after having fasted for 6 hours (water permitted) and sign a consent form. They will rinse their mouth with water and provide a breath sample. An additional environment sample will also be collected. Participants will answer questions about their medical and drug history.

  • Liver Arm

    Cases will be patients with histology-confirmed, treatment naïve hepatocellular carcinoma (HCC) and cholangiocarcinoma (CCC) and controls will be patients with non-specific abdominal symptoms with a radiologically-normal liver as diagnosed on the reference test (ultrasound, MRI, CT and PET-CT). All eligible patients will be invited to participate. Participants will attend a one-off research visit, after having fasted for 6 hours (water permitted) and sign a consent form. They will rinse their mouth with water and provide a breath sample. An additional environment sample will also be collected. Participants will answer questions about their medical and drug history.

  • Colorectal Arm

    Cases will be patients with histology-confirmed, treatment naïve colorectal adenocarcinoma (CRC) and controls will be patients with non-specific abdominal symptoms with a normal lower GI tract or benign condition of the colon as diagnosed on the reference test (colonoscopy). All eligible patients will be invited to participate. Participants will attend a one-off research visit, after having fasted for 6 hours (water permitted) and sign a consent form. They will rinse their mouth with water and provide a breath sample. An additional environment sample will also be collected. Participants will answer questions about their medical and drug history.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Breath Research Narrow Validation for Gastrointestinal Cancer Detection
Plain-language title
Breath test to help detect cancers of the digestive systemGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
22 October 2026