Breath Research Narrow Validation for Gastrointestinal Cancer Detection

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorImperial College London

About this trial

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

Eligibility criteria

Qualifiers

Cancer: Histologically-confirmed CRC*

Control: Non-specific abdominal symptoms with normal or benign colonoscopy findings

Cancer: Histologically-confirmed PDAC*

Control: Non-specific abdominal symptoms with a radiologically-normal pancreas

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

1,000 Participants
are grouped into 5 trial groups

Sponsors and collaborators

Imperial College London

Lead sponsor

Imperial College Healthcare NHS Trust

Collaborator

Maidstone & Tunbridge Wells NHS Trust

Collaborator

Royal Liverpool University Hospital

Collaborator

The Clatterbridge Cancer Centre NHS Foundation Trust

Collaborator

Hull University Teaching Hospitals NHS Trust

Collaborator

Royal Free London NHS Foundation Trust

Collaborator

NHS Greater Glasgow and Clyde

Collaborator

Chelsea and Westminster NHS Foundation Trust

Collaborator

St George's Healthcare NHS Trust

Collaborator