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NCT Number: NCT07243262

Volatile Organic Compound Assessment in Pancreatic Ductal Adenocarcinoma (VAPOR2)

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site PDAC - Pancreatic Ductal Adenocarcinoma Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Imperial College Healthcare NHS Trust

London, United Kingdom

Location status: Recruiting

Location contact

Caoimhe Walsh

CONTACT

[email protected]

Emma Austin

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Validation of a triage breath test for detecting pancreatic ductal adenocarcinoma in 6079 participants referred from primary care with potential underlying pancreatic cancer.

    Time frame: 36 months

    Estimation of sensitivity, specificity and numbers of false positives (with 95% confidence intervals) for a breath test to detect pancreatic ductal adenocarcinoma

Secondary outcomes

  1. To test feasibility of the breath test in a large population

    Time frame: 36 months

    Feasibility of the breath test in a large population will be reported as the proportion of tests that were completed and analysed.

  2. Economic modelling for scaling up breath testing into clinical practice.

    Time frame: 36 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Caoimhe Walsh, MBBS, MRCS

CONTACT

[email protected]

+44 (0)20 7594 3653

Emma Austin

CONTACT

[email protected]

+44 (0)20 7594 3653

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Aneurin Bevan University Health Board
  • Betsi Cadwaladr University Health Board
  • Buckinghamshire Healthcare NHS Trust
  • County Durham and Darlington NHS Foundation Trust
  • Dorset County Hospital NHS Foundation Trust
  • Imperial College Healthcare NHS Trust
  • Kettering General Hospital NHS Foundation Trust
  • Liverpool University Hospitals NHS Foundation Trust
  • NHS Fife
  • Newcastle-upon-Tyne Hospitals NHS Trust
  • North Tees and Hartlepool NHS Foundation Trust
  • Northampton General Hospital NHS Trust
  • Pancreatic Cancer UK
  • Royal Free Hospital NHS Foundation Trust
  • Sheffield Teaching Hospitals NHS Foundation Trust
  • Sherwood Forest Hospitals NHS Foundation Trust
  • Somerset NHS Foundation Trust
  • The Leeds Teaching Hospitals NHS Trust
  • University Hospital Birmingham NHS Foundation Trust
  • University Hospital Plymouth NHS Trust
  • University Hospital Southampton NHS Foundation Trust
  • Upton Surgery, Worcester
  • Worcestershire Acute Hospitals NHS Trust

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 21, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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