Volatile Organic Compound Assessment in Pancreatic Ductal Adenocarcinoma (VAPOR2)

May 15, 2026 updated by: Imperial College London

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

6079

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: Breath 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
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
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 months
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.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

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

Investigators

  • Principal Investigator: Professor George B Hanna, PhD, FRCS, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2025

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 177986

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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