Volatile Organic Compound Assessment in Pancreatic Ductal Adenocarcinoma
VAPOR
1 other identifier
observational
1,005
1 country
1
Brief Summary
Patients with early pancreatic cancer often have symptoms that could also be caused by many common benign conditions, or no symptoms at all. Jaundice, weight loss and pain are 'red flag' symptoms of pancreatic cancer that are linked to incurable disease. At the moment only patients with 'red flag' symptoms are urgently referred for diagnostic testing to find out if they have the cancer. As a result, late diagnosis is a common feature of pancreatic cancer. This leads to limited treatment options being available to patients by the time they are diagnosed, and ultimately results in poor survival rates. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 15, 2022
CompletedFirst Submitted
Initial submission to the registry
January 23, 2023
CompletedFirst Posted
Study publicly available on registry
February 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedMarch 24, 2026
March 1, 2026
3.4 years
January 23, 2023
March 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Levels of VOCs present in breath of subjects with PDAC and controls
Gas Chromatography-Mass Spectrometry (GC-MS) will be used to identify the levels (measured in parts per billion, ppb) of certain cancer-associated VOCs in breath
24 months
Secondary Outcomes (3)
Levels of volatile metabolites present in headspace of the urine of subjects with PDAC and controls
24 months
Characterisation of bacterial species in saliva samples, pancreatic tissue samples and duodenal aspirate samples of subjects with PDAC compared to controls
24 months
Levels of VOCs produced by the bacteria isolated from saliva samples, pancreatic tissue samples and duodenal aspirate samples of subjects with PDAC
24 months
Study Arms (5)
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.
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.
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.
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.
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.
Interventions
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.
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
Patients seen in a hospital (secondary or tertiary level care) setting or at an NHS diabetes centre.
You may qualify if:
- Males and females
- 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.
You may not qualify if:
- Patients who have already received chemotherapy, radiotherapy or surgery for their PDAC
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royal Free Hospital NHS Foundation Trustcollaborator
- The Leeds Teaching Hospitals NHS Trustcollaborator
- Sheffield Teaching Hospitals NHS Foundation Trustcollaborator
- Royal Surrey County Hospital NHS Foundation Trustcollaborator
- Manchester University NHS Foundation Trustcollaborator
- Newcastle-upon-Tyne Hospitals NHS Trustcollaborator
- Swansea Bay University Health Boardcollaborator
- North Tees and Hartlepool NHS Foundation Trustcollaborator
- University Hospital Plymouth NHS Trustcollaborator
- Barts & The London NHS Trustcollaborator
- Milton Keynes University Hospital NHS Foundation Trustcollaborator
- Buckinghamshire Healthcare NHS Trustcollaborator
- Southern Healthcollaborator
- Imperial College Londonlead
- Pancreatic Cancer UKcollaborator
- Imperial College Healthcare NHS Trustcollaborator
- Liverpool University Hospitals NHS Foundation Trustcollaborator
- University Hospital Southampton NHS Foundation Trustcollaborator
- University Hospital Birmingham NHS Foundation Trustcollaborator
- Dorset County Hospital NHS Foundation Trustcollaborator
Study Sites (1)
Imperial College Healthcare NHS Trust
London, United Kingdom
Related Publications (1)
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.
PMID: 40866056DERIVED
Biospecimen
Breath, Saliva, Blood, Urine, Pancreatic tissue, Duodenal aspirate
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Professor George B Hanna, PhD, FRCS
Imperial College London
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2023
First Posted
February 14, 2023
Study Start
December 15, 2022
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
March 24, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share