Volatile Organic Compound Assessment in Pancreatic Ductal Adenocarcinoma
NCT ID: NCT05727020
Last Updated: 2025-10-01
Study Results
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.
RECRUITING
1005 participants
OBSERVATIONAL
2022-12-15
2026-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
There is a clear need to improve earlier detection of pancreatic cancer so that patients with pancreatic cancer can be identified earlier and faster, enabling them to start treatment more quickly.
The study team is developing a non-invasive breath test that detects small molecules called volatile organic compounds (VOCs) that may be altered by pancreatic cancers. For patients with non-specific symptoms, this test would help general practitioners (GPs) to identify those patients that may indeed have an underlying pancreatic cancer, who would benefit from referral for specialised pancreatic cancer tests.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Volatile Organic Compound Assessment in Pancreatic Ductal Adenocarcinoma (VAPOR2)
NCT07243262
Pancreatic Cancer Dietary Assessment Study
NCT03616431
Early Detection of Pancreatic Adenocarcinoma (PDAC) Using a Panel of Biomarkers
NCT04449406
Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals
NCT06122896
Diagnostic Accuracy of Circulating Tumor Cells (CTCs) and Onco-exosome Quantification in the Diagnosis of Pancreatic Cancer - PANC-CTC
NCT03032913
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
VAPOR 1 clinical study: Up to 813 patients will be recruited for the development of this non-invasive PDAC detection model. This will be comprised of three groups: (i) patients with PDAC; (ii) control patients with specified benign pancreatic disorders (new-onset diabetes mellitus, or chronic pancreatitis); (iii) control patients with non-specific gastrointestinal symptoms but a radiologically-normal pancreas. Participants will be required to fast for 6 hours prior to breath sampling. After rinsing their mouth with water, patients will be asked to provide breath samples by exhaling into single-use breath collection bags. Breath will be transferred using a precision pump into thermal desorption (TD) storage tubes. Breath samples will be analysed in accordance with existing quality-controlled processes.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
VAPOR 1 - PDAC (pancreatic ductal adenocarcinoma)
304 treatment-naive patients with histologically-confirmed\* PDAC will be recruited to provide breath samples.
\*Patients that are due to undergo surgery for suspected PDAC (without pre-operative histological confirmation) may still be recruited despite the lack of pre-operative histological confirmation, assuming PDAC is subsequently confirmed within the resected specimen.
Breath test
Patients must be fasted for a minimum of six hours prior to sample collection. For patients undergoing surgery or a procedure (e.g. endoscopy), breath samples must be obtained pre-operatively / prior to the administration of sedation, anaesthetic or other pharmacological agents.
VAPOR 1 - Control patients with benign pancreatic disorders
257 patients with new-onset diabetes mellitus or chronic pancreatitis will be recruited to provide breath samples.
New-onset diabetes is defined as: HbA1c≥48mmol/mol (6.5%), diagnosed within the preceding 6 months.
Breath test
Patients must be fasted for a minimum of six hours prior to sample collection. For patients undergoing surgery or a procedure (e.g. endoscopy), breath samples must be obtained pre-operatively / prior to the administration of sedation, anaesthetic or other pharmacological agents.
VAPOR 1 - Control patients with non-specific GI symptoms and a normal pancreas
257 patients with non-specific gastrointestinal symptoms but a radiologically-normal pancreas will be recruited to provide breath samples.
Imaging to confirm a normal pancreas (CT / MRI / ultrasound) must have occurred within the preceding 12 months.
Breath test
Patients must be fasted for a minimum of six hours prior to sample collection. For patients undergoing surgery or a procedure (e.g. endoscopy), breath samples must be obtained pre-operatively / prior to the administration of sedation, anaesthetic or other pharmacological agents.
VAPOR Bioresource - PDAC (pancreatic ductal adenocarcinoma)
96 treatment-naive patients with histologically-confirmed\* PDAC will be recruited to provide samples of breath, saliva, blood, urine, pancreatic tissue and duodenal aspirate.
\*Patients that are due to undergo surgery for suspected PDAC (without pre-operative histological confirmation) may still be recruited despite the lack of pre-operative histological confirmation, assuming PDAC is subsequently confirmed within the resected specimen.
Collection of matched samples of breath, biofluids and pancreatic tissue
In accordance with routine clinical practices, patients will be fasted for a minimum of six hours prior to surgery. Exhaled breath, saliva, blood and urine will be collected immediately prior to surgery (before induction of general anaesthesia). Pancreatic tissue samples and duodenal aspirate which will be collected upon resection of the pancreatic specimen.
VAPOR Bioresource - Control patients with benign pancreatic disorders
96 patients with benign pancreatic disorders (such as intraductal papillary mucinous neoplasms, pancreatic mucinous cystic neoplasms, chronic pancreatitis) will be recruited to provide samples of breath, saliva, blood, urine, pancreatic tissue and duodenal aspirate.
Collection of matched samples of breath, biofluids and pancreatic tissue
In accordance with routine clinical practices, patients will be fasted for a minimum of six hours prior to surgery. Exhaled breath, saliva, blood and urine will be collected immediately prior to surgery (before induction of general anaesthesia). Pancreatic tissue samples and duodenal aspirate which will be collected upon resection of the pancreatic specimen.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Breath test
Patients must be fasted for a minimum of six hours prior to sample collection. For patients undergoing surgery or a procedure (e.g. endoscopy), breath samples must be obtained pre-operatively / prior to the administration of sedation, anaesthetic or other pharmacological agents.
Collection of matched samples of breath, biofluids and pancreatic tissue
In accordance with routine clinical practices, patients will be fasted for a minimum of six hours prior to surgery. Exhaled breath, saliva, blood and urine will be collected immediately prior to surgery (before induction of general anaesthesia). Pancreatic tissue samples and duodenal aspirate which will be collected upon resection of the pancreatic specimen.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Adult patients ≥ 18 years old
* VAPOR 1: patients with either a) Histologically confirmed PDAC\*; b) New-onset diabetes mellitus or chronic pancreatitis; or c) Non-specific gastrointestinal symptoms, but a radiologically-normal pancreas
* VAPOR Bioresource: patients undergoing pancreatic resection for a) Histologically confirmed PDAC\*; or b) Benign pancreatic disorders e.g. intraductal papillary mucinous neoplasms, pancreatic mucinous cystic neoplasms, chronic pancreatitis
Note: \*Patients undergoing surgery for suspected PDAC (without pre-operative histological confirmation) may be recruited assuming PDAC is confirmed within the resected specimen.
Exclusion Criteria
* History of another cancer within the previous five years
* Previous upper gastrointestinal surgery
* Patients who are unable to provide a breath sample
* Pregnant women
* Patients unable to provide informed written consent
* VAPOR 1: Patients with active infection, receiving immunosuppressive medications or antibiotics within the preceding eight weeks
* VAPOR Bioresource: Patients receiving immunosuppressive medications within the preceding eight weeks
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pancreatic Cancer UK
OTHER
Imperial College Healthcare NHS Trust
OTHER
Royal Free Hospital NHS Foundation Trust
OTHER
Liverpool University Hospitals NHS Foundation Trust
OTHER_GOV
The Leeds Teaching Hospitals NHS Trust
OTHER
Sheffield Teaching Hospitals NHS Foundation Trust
OTHER
University Hospital Southampton NHS Foundation Trust
OTHER
Royal Surrey County Hospital NHS Foundation Trust
OTHER
University Hospital Birmingham NHS Foundation Trust
OTHER
Manchester University NHS Foundation Trust
OTHER_GOV
Newcastle-upon-Tyne Hospitals NHS Trust
OTHER
Swansea Bay University Health Board
OTHER
Dorset County Hospital NHS Foundation Trust
OTHER_GOV
North Tees and Hartlepool NHS Foundation Trust
OTHER
University Hospital Plymouth NHS Trust
OTHER
Barts & The London NHS Trust
OTHER
Milton Keynes University Hospital NHS Foundation Trust
OTHER_GOV
Buckinghamshire Healthcare NHS Trust
OTHER
Southern Health
OTHER
Imperial College London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Professor George B Hanna, PhD, FRCS
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Imperial College Healthcare NHS Trust
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Walsh CM, Murray J, Laponogov I, Parker A, Ellis JK, Converso V, Austin E, Boshier PR, Czajkowski C, Spalding D, Al-Mukhtar A, Frampton AE, Roberts KJ, Pandanaboyana S, Halloran C, Costello E, Kocher H, Mitra V, Hamady Z, Al-Sarireh B, Pathak S, Mitchell WK, Siriwardena AK, Westlake C, Pereira SP, Spiliotis I, Biswas S, Vapor Collaborators, Spanel P, Veselkov K, Sharples LD, Hanna GB; VAPOR Collaborators. Development and validation of a diagnostic prediction model for pancreatic ductal adenocarcinoma: VAPOR 1, protocol for a prospective multicentre case-control study. BMJ Open. 2025 Aug 27;15(8):e094505. doi: 10.1136/bmjopen-2024-094505.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
22HH7787
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.