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| Name | Class |
|---|---|
| Pancreatic Cancer UK | OTHER |
| Imperial College Healthcare NHS Trust | OTHER |
| Royal Free Hospital NHS Foundation Trust | OTHER |
| Liverpool University Hospitals NHS Foundation Trust |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breath test | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 36 months |
| Economic modelling for scaling up breath testing into clinical practice. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emma Austin | Contact | +44 (0)20 7594 3653 | vapor@imperial.ac.uk | |
| Caoimhe Walsh, MBBS, MRCS | Contact | +44 (0)20 7594 3653 | vapor@imperial.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Professor George B Hanna, PhD, FRCS | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | Recruiting | London | United Kingdom |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D001944 | Breath Tests |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| OTHER_GOV |
| Newcastle-upon-Tyne Hospitals NHS Trust | OTHER |
| University Hospital Southampton NHS Foundation Trust | OTHER |
| Sherwood Forest Hospitals NHS Foundation Trust | OTHER |
| Buckinghamshire Healthcare NHS Trust | OTHER |
| The Leeds Teaching Hospitals NHS Trust | OTHER |
| Dorset County Hospital NHS Foundation Trust | OTHER_GOV |
| Sheffield Teaching Hospitals NHS Foundation Trust | OTHER |
| Kettering General Hospital NHS Foundation Trust | OTHER |
| County Durham and Darlington NHS Foundation Trust | OTHER_GOV |
| North Tees and Hartlepool NHS Foundation Trust | OTHER |
| University Hospital Birmingham NHS Foundation Trust | OTHER |
| Betsi Cadwaladr University Health Board | OTHER_GOV |
| Northampton General Hospital NHS Trust | OTHER |
| NHS Fife | OTHER_GOV |
| Somerset NHS Foundation Trust | OTHER |
| Aneurin Bevan University Health Board | OTHER |
| Worcestershire Acute Hospitals NHS Trust | OTHER |
| University Hospital Plymouth NHS Trust | OTHER |
| Upton Surgery, Worcester | UNKNOWN |
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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. |
| 36 months |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |