Volatile Organic Compound Assessment in Pancreatic Ductal Adenocarcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorImperial College London
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients seen in a hospital (secondary or tertiary level care) setting or at an NHS diabetes centre.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Breath test
Diagnostic testPatients 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
Diagnostic testIn 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.
Treatment groups
1,005 Participants
are divided into 5 treatment groupsGroup A: VAPOR 1 - PDAC (pancreatic ductal adenocarcinoma)1 intervention
Group B: VAPOR 1 - Control patients with benign pancreatic disorders1 intervention
Group C: VAPOR 1 - Control patients with non-specific GI symptoms and a normal pancreas1 intervention
Group D: VAPOR Bioresource - PDAC (pancreatic ductal adenocarcinoma)1 intervention
Group E: VAPOR Bioresource - Control patients with benign pancreatic disorders1 intervention
Trial outcomes
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
Time frame
24 monthsSecondary outcomes
1
Levels of volatile metabolites present in headspace of the urine of subjects with PDAC and controls
Headspace sampling techniques will be used for headspace collection from urine samples. GC-MS will be used to determine the levels (measured in parts per billion, ppb) of certain cancer-associated VOCs within the headspace of urine.
Time frame
24 months2
Characterisation of bacterial species in saliva samples, pancreatic tissue samples and duodenal aspirate samples of subjects with PDAC compared to controls
Bacterial species present will be identified (measured) using sequencing techniques such as 16s or whole genome sequencing. * Bacteria within the saliva samples will be cultured and species isolated * Bacteria from pancreatic biopsies will be separated from the tissue, and will be cultured to isolate the bacterial species * Bacteria derived from duodenal aspirate will be cultured and species isolated
Time frame
24 months3
Levels of VOCs produced by the bacteria isolated from saliva samples, pancreatic tissue samples and duodenal aspirate samples of subjects with PDAC
The cancer-associated bacterial species isolated and identified as part of Outcome Measure 3 will then be re-cultured within a controlled environment. Headspace and media sampling will be performed to identify and measure the levels of volatile metabolites (measured in parts per billion, ppb) present using GC-MS and LC-MS (Liquid Chromatography-Mass Spectrometry) techniques.
Time frame
24 monthsSponsors and contacts
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Imperial College London
Lead sponsor
Pancreatic Cancer UK
Collaborator
Imperial College Healthcare NHS Trust
Collaborator
Royal Free Hospital NHS Foundation Trust
Collaborator
Liverpool University Hospitals NHS Foundation Trust
Collaborator
The Leeds Teaching Hospitals NHS Trust
Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborator
University Hospital Southampton NHS Foundation Trust
Collaborator
Royal Surrey County Hospital NHS Foundation Trust
Collaborator
University Hospital Birmingham NHS Foundation Trust
Collaborator
Manchester University NHS Foundation Trust
Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborator
Swansea Bay University Health Board
Collaborator
Dorset County Hospital NHS Foundation Trust
Collaborator
North Tees and Hartlepool NHS Foundation Trust
Collaborator
University Hospital Plymouth NHS Trust
Collaborator
Barts & The London NHS Trust
Collaborator
Milton Keynes University Hospital NHS Foundation Trust
Collaborator
Buckinghamshire Healthcare NHS Trust
Collaborator
Southern Health
Collaborator
Source ClinicalTrials.gov