Volatile Organic Compound Assessment in Pancreatic Ductal Adenocarcinoma (VAPOR2)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

6079 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-21

Study Completion Date

2028-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Volatile Organic Compound Assessment in Pancreatic Ductal Adenocarcinoma

NCT05727020

PDAC - Pancreatic Ductal Adenocarcinoma Pancreatic Cancer

RECRUITING

Early Detection of Pancreatic Adenocarcinoma (PDAC) Using a Panel of Biomarkers

NCT04449406

Pancreatic Ductal Adenocarcinoma

RECRUITING

Pancreatic Cancer Dietary Assessment Study

NCT03616431

Pancreatic Neoplasm Pancreas Adenocarcinoma Well-Differentiated Neuroendocrine Carcinoma +1 more

COMPLETED

Identification of Immunogenic Neo-epitopes for the Development of Personalised Pancreatic Cancer Vaccines

NCT04379960

The Initial Aim of This Project is to Perform in Vitro Validation of Neoepitope Candidates Selected From Available Mutanome Data

COMPLETED

PDAC Peripheral and Portal Vein Sampling

NCT04289961

Pancreatic Adenocarcinoma

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Cancer PDAC - Pancreatic Ductal Adenocarcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Breath test

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No