Breath test to detect pancreatic ductal adenocarcinoma (VAPOR2)
Volatile Organic Compound Assessment in Pancreatic Ductal Adenocarcinoma (VAPOR2)
This research will try a non-invasive breath test that looks for volatile organic compounds to see if it can detect pancreatic cancer in adults referred from primary care with possible pancreatic symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6079 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT07243262 on ClinicalTrials.gov |
What this trial studies
VAPOR2 is a multicentre, double-blind external validation effort to test a breath-based volatile organic compound (VOC) signature for pancreatic ductal adenocarcinoma in 6,079 adults referred from primary care. Breath samples will be analysed by laboratory VOC analysts and classified by blinded statisticians and bioinformaticians, while radiologists and pathologists reading CT, MRI, or biopsy results will not see breath results. Breath test and definitive diagnostic data will be cleaned and locked separately before being combined for analysis, with the lead statistician unblinded only at prespecified interim and final analyses. The goal is to measure the accuracy of the VOC-based prediction models against standard diagnostic pathways.
Who should consider this trial
Good fit: Adults aged 18 and over who have been referred from primary care under urgent suspected cancer guidelines or referred directly to a pancreatic multidisciplinary team for possible pancreatic cancer are the intended participants.
Not a fit: People with prior pancreatic resection, a history of another cancer within three years, pregnant participants, those with co-morbidities preventing breath collection, or those unable or unwilling to consent are excluded and unlikely to benefit from this test.
Why it matters
Potential benefit: If successful, the breath test could help doctors find pancreatic cancer earlier using a simple, non-invasive sample, potentially increasing treatment options.
How similar studies have performed: Earlier pilot and early-phase breath-VOC studies for pancreatic and other cancers have shown promising signals but have not been validated in large, blinded multicentre cohorts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult participants ≥ 18 years old * Referral from primary care according to the urgent suspected cancer referral guidelines for potential underlying pancreatic cancer, or referral directly to a pancreatic cancer multidisciplinary team meeting Exclusion Criteria: * Previous pancreatic resection * History of another cancer (other than non-melanoma skin cancers) within three years * Pregnant participants (pregnancy status to be confirmed verbally with the participant) * Participants with co-morbidities preventing breath collection * Unable or unwilling to provide informed consent
Where this trial is running
London
- Imperial College Healthcare NHS Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Professor George B Hanna, PhD, FRCS — Imperial College London
- Study coordinator: Emma Austin
- Email: vapor@imperial.ac.uk
- Phone: +44 (0)20 7594 3653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.