About this trial
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.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Breath test
Diagnostic testAll 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
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.
Sponsors and contacts
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Imperial College London
Lead sponsor
Pancreatic Cancer UK
Collaborator
Imperial College Healthcare NHS Trust
Collaborator
Royal Free Hospital NHS Foundation Trust
Collaborator
Liverpool University Hospitals NHS Foundation Trust
Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborator
University Hospital Southampton NHS Foundation Trust
Collaborator
Sherwood Forest Hospitals NHS Foundation Trust
Collaborator
Buckinghamshire Healthcare NHS Trust
Collaborator
The Leeds Teaching Hospitals NHS Trust
Collaborator
Dorset County Hospital NHS Foundation Trust
Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborator
Kettering General Hospital NHS Foundation Trust
Collaborator
County Durham and Darlington NHS Foundation Trust
Collaborator
North Tees and Hartlepool NHS Foundation Trust
Collaborator
University Hospital Birmingham NHS Foundation Trust
Collaborator
Betsi Cadwaladr University Health Board
Collaborator
Northampton General Hospital NHS Trust
Collaborator
NHS Fife
Collaborator
Somerset NHS Foundation Trust
Collaborator
Aneurin Bevan University Health Board
Collaborator
Worcestershire Acute Hospitals NHS Trust
Collaborator
University Hospital Plymouth NHS Trust
Collaborator
Upton Surgery, Worcester
Collaborator