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NCT07714538Recruiting

Breath Research Narrow Validation for Gastrointestinal Cancer Detection

Source: ClinicalTrials.gov · Last updated 22 Oct 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Observational
Enrollment
1000 (estimated)
First submitted
15 Jul 2026
Start date
26 Jul 2026
Primary completion date
2 Feb 2029
Lead sponsor
Imperial College London
NCT number
NCT07714538

What you commit to

  • Study type: Observational
  • Planned participants: 1000
  • From 26 Jul 2026 to the primary completion date, 2 Feb 2029
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • History of another cancer (other than non-melanoma skin cancers) within three years

Lab values

  • (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

Other

  • Participants with co-morbidities preventing breath collection
  • Unable or unwilling to provide informed consent

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
NHS Greater Glasgow and Clyde
Coordinator of this site? Confirm its status
GlasgowUnited KingdomNot yet recruiting
Liverpool University Hospitals NHS Foundation Trust
Coordinator of this site? Confirm its status
LiverpoolUnited KingdomNot yet recruiting
The Clatterbridge Cancer Centre NHS Foundation Trust
Coordinator of this site? Confirm its status
LiverpoolUnited KingdomNot yet recruiting
Imperial College Healthcare NHS Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Royal Free London NHS Foundation Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomNot yet recruiting
Maidstone and Tunbridge Wells NHS Trust
Coordinator of this site? Confirm its status
MaidstoneUnited KingdomNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.