Pancreatic CancerNCT07243262
Volatile Organic Compound Assessment in Pancreatic Ductal Adenocarcinoma (VAPOR2)
An observational study of Pancreatic Cancer and PDAC - Pancreatic Ductal Adenocarcinoma, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The investigators are developing a non-invasive breath test to help us detect pancreatic cancer earlier. The test detects small molecules called volatile organic compounds that are made by pancreatic cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, PDAC - Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Breath test
- How many people
- 6,079 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Oct 2025to 1 Aug 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants above the age of 18 years with potential underlying pancreatic cancer referred from primary care according to urgent suspected cancer referral guidelines will be invited to participate in the study. In addition, participants referred directly to a pancreatic cancer multidisciplinary team meeting will also be invited to participate in the study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London
Emma Austin, vapor@imperial.ac.uk
Caoimhe Walsh, vapor@imperial.ac.uk
About this study
The investigators are developing a non-invasive breath test to help us detect pancreatic cancer earlier. The test detects small molecules called volatile organic compounds that are made by pancreatic cancers.
Pancreatic cancer is a rare disease but patients are often diagnosed at a late stage because their symptoms are the same as those of many common illnesses. This makes it hard for doctors to know which patients need to be tested for pancreatic cancer. If the investigators find pancreatic cancer at a late stage, it reduces the number of treatment choices for patients.
Read more
Our test could be offered to patients who are experiencing vague symptoms, which might be caused either by pancreatic cancer or a common illness. This test could help doctors to identify which of those patients may have pancreatic cancer, and ensure they get referred for specialised pancreatic cancer tests. The investigators hope that this will allow us to diagnose pancreatic cancer earlier, increasing treatment choices for patients and improving survival from pancreatic cancer.
The investigators have previously conducted a study (VAPOR1) which collected breath samples from people with and without pancreatic cancer. When the investigators analysed these samples, they found that there is a difference in the volatile organic compounds breathed out by people who have pancreatic cancer compared to those that do not. The investigators used these 'markers' to develop a breath test to diagnose pancreatic cancer. In VAPOR2, the investigators will study our breath test in a much larger group of patients who have been referred for further investigations for potential underlying pancreatic cancer to see how accurately it can pick up the small percentage of people who have pancreatic cancer.
Read the detailed description
A multicentre double-blind external validation study to validate the breath test to detect PDAC in 6079 adult participants referred from primary care with potential underlying pancreatic cancer, whereby the VOC analyst in the laboratory and the statistician and bioinformatician classifying the VOC profile into cancer/no-cancer will be blinded to the definitive diagnosis of cancer/no-cancer at the time of analysis. Additionally, the radiologist and/or pathologist reporting the reference test (CT, MRI, biopsy) will not have access to the breath test results at any point. Breath test analysis and definitive diagnoses will be held in separate datasets, which will be cleaned and locked before being combined for analysis. The lead statistician will be unblinded at the interim analysis and at the end of the study after the final database lock once all the study data has been collected and cleaned, to calculate the accuracy of the prediction models.
- Being tested
- Breath test
- Keywords
- Volatile organic compounds (VOCs), Breath analysis, Volatolomics, Validation, Early detection of cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath testDiagnostic test
All participants will fast for a minimum of six hours prior to breath collection. For participants undergoing a procedure, breath samples must be obtained prior to administration of sedation, anaesthetic or other pharmacological agents. After providing written informed consent, participants will be asked to rinse their mouth with water and then provide a breath sample by exhaling into single-use breath collection bags via a mouthpiece that is subsequently sealed.
| Study group | Role | What they receive |
|---|---|---|
| VAPOR2 Participants | 6079 participants above the age of 18 years with potential underlying pancreatic cancer referred from primary care according to urgent suspected cancer referral guidelines or referred directly to a pancreatic cancer multidisciplinary team meeting. Receives: Diagnostic Test: Breath test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of a triage breath test for detecting pancreatic ductal adenocarcinoma in 6079 participants referred from primary care with potential underlying pancreatic cancer.
Estimation of sensitivity, specificity and numbers of false positives (with 95% confidence intervals) for a breath test to detect pancreatic ductal adenocarcinoma
Measured: 36 months
Secondary outcomes (2)
To test feasibility of the breath test in a large population
Feasibility of the breath test in a large population will be reported as the proportion of tests that were completed and analysed.
Measured: 36 months
Economic modelling for scaling up breath testing into clinical practice.
To assess the cost-benefit trade-offs of using the breath test in the symptomatic population referred for suspicion of PDAC. To inform its utilisation within the NHS, the specific objectives are to:
(i) map out current and breath test-assisted clinical pathways for PDAC referrals; (ii) estimate the health economic impact for the NHS by adopting the augmented breath test; and (iii) consider barriers to adoption and develop mitigation strategies for scaling-up in clinical practice.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start21 Oct 2025
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,079 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Pancreatic Cancer UK, Imperial College Healthcare NHS Trust, Royal Free Hospital NHS Foundation Trust, Liverpool University Hospitals NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, University Hospital Southampton NHS Foundation Trust, Sherwood Forest Hospitals NHS Foundation Trust, Buckinghamshire Healthcare NHS Trust, The Leeds Teaching Hospitals NHS Trust, Dorset County Hospital NHS Foundation Trust, Sheffield Teaching Hospitals NHS Foundation Trust, Kettering General Hospital NHS Foundation Trust, County Durham and Darlington NHS Foundation Trust, North Tees and Hartlepool NHS Foundation Trust, University Hospital Birmingham NHS Foundation Trust, Betsi Cadwaladr University Health Board, Northampton General Hospital NHS Trust, NHS Fife, Somerset NHS Foundation Trust, Aneurin Bevan University Health Board, Worcestershire Acute Hospitals NHS Trust, University Hospital Plymouth NHS Trust, Upton Surgery, Worcester
- Responsible party
- Sponsor
- Investigators
- Professor George B Hanna, PhD, FRCS, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243262
- Sponsor's protocol ID
- 177986
- Status last verified
- Jul 2026
- First submitted
- 17 Nov 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No