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
This trial does not accept healthy volunteersQualifiers
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 population
Adult Participants who meet the eligibility criteria and are being referred for further specialised investigations within the NHS.
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
To validate and refine a series of breath tests to detect the following conditions: CRC, PDAC, OGC, OSCC, HCC and CCC
Estimation of sensitivity, specificity and numbers of false positives (with 95% confidence intervals) for breath tests to detect CRC, PDAC, OGC, OSCC, HCC and CCC.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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