Breath Research Narrow Validation for Gastrointestinal Cancer Detection (NCT07714538) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Breath Research Narrow Validation for Gastrointestinal Cancer Detection
United Kingdom1,000 participantsStarted 2026-07-20
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Cancer: Histologically-confirmed OGC\*
. Control: Non-specific abdominal symptoms with normal or benign upper gastrointestinal endoscopy findings
. Cancer: Histologically-confirmed OSCC\*
. Control: Non-specific abdominal symptoms with normal or benign upper gastrointestinal endoscopy findings
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing breath tests to detect cancers like the one I've been diagnosed with — could my doctor explain how a breath test actually works for detecting gastrointestinal cancers, and how reliable this approach has been so far in earlier research?
2Since this trial is listed as 'not yet recruiting,' can my doctor help me find out when it might open and whether it would even be worth waiting for it, or whether I should pursue standard diagnostic or treatment pathways now?
3The trial covers several different cancer types including mine — can my doctor explain whether the breath test being studied here would be used as a screening or diagnostic tool, and how that might or might not be relevant to my specific situation?
4Because this study is categorized as phase 'NA,' which suggests it may be a validation or observational study rather than a treatment trial, can my doctor clarify what participation would actually involve for me — such as whether there are any risks, time commitments, or procedures beyond providing a breath sample?
5If I were to eventually participate in a study like this, would it run alongside my current treatment plan, or are there any conditions or medications I have that might affect the breath test results and make my participation less suitable?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To validate and refine a series of breath tests to detect the following conditions: CRC, PDAC, OGC, OSCC, HCC and CCC