Volatile Organic Compound Assessment In Pancreatic Ductal Adenocarcinoma

Study Overview

Volatile Organic Compound Assessment in Pancreatic Ductal Adenocarcinoma

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.

Bioresource study to identify pathways responsible for VOC production: A total of 192 patients will be recruited to provide samples to create a pancreatic biobank. This will be comprised of two groups, each containing 96 patients: (i) patients undergoing resection for pancreatic ductal adenocarcinoma (PDAC); (ii) control patients undergoing pancreatic resection for benign pancreatic disorders (e.g. intraductal papillary mucinous neoplasms, pancreatic mucinous cystic neoplasms, chronic pancreatitis). The following biosamples will be collected from each patient: breath, saliva, blood, urine, pancreatic tissue, duodenal aspirate. Collected samples will be stored in a biobank and will be utilised in a wide range of studies to investigate the mechanisms of VOC production in PDAC. The following analyses will be undertaken: volatolomics, metabonomics / lipidomics, metagenomics / microbiome analysis, transcriptomics, and culture experiments (to establish bacterial, immune and organoid cultures). VAPOR 1 clinical study: A total of 771 patients will be recruited for the development of this non-invasive PDAC detection model. This will be comprised of three groups, each containing 257 patients: (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.

PDAC - Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer

DIAGNOSTIC_TEST: Breath test
DIAGNOSTIC_TEST: Collection of matched samples of breath, biofluids and pancreatic tissue

22HH7787

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-01-23	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-01-23
First Submitted that Met QC Criteria 2023-02-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-03-25
First Posted (ACTUAL) 2023-02-14	Results First Posted N/A	Last Verified 2025-01

Study Plan

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

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: VAPOR 1 - PDAC (pancreatic ductal adenocarcinoma) 257 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 th	DIAGNOSTIC_TEST: 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
: 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.	DIAGNOSTIC_TEST: 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
: 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.	DIAGNOSTIC_TEST: 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
: 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-opera	DIAGNOSTIC_TEST: 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). Pancreati
: 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 duodena	DIAGNOSTIC_TEST: 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). Pancreati

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
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.	24 months
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	24 months
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.	24 months

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

Name: Miss Caoimhe M Walsh, MBBS, MRCS

Phone Number: +44 (0)20 7594 3653

Email: vapor@imperial.ac.uk

Study Contact Backup

Name: Emma Austin

Phone Number: +44 (0)20 7594 3653

Email: vapor@imperial.ac.uk

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

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

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

Collaborators and Investigators

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

Pancreatic Cancer UK
Imperial College Healthcare NHS Trust
Royal Free Hospital NHS Foundation Trust
Liverpool University Hospitals NHS Foundation Trust
The Leeds Teaching Hospitals NHS Trust
Sheffield Teaching Hospitals NHS Foundation Trust
University Hospital Southampton NHS Foundation Trust
Royal Surrey County Hospital NHS Foundation Trust
University Hospital Birmingham NHS Foundation Trust
Manchester University NHS Foundation Trust
Newcastle-upon-Tyne Hospitals NHS Trust
Swansea Bay University Health Board
Dorset County Hospital NHS Foundation Trust
North Tees and Hartlepool NHS Foundation Trust
University Hospital Plymouth NHS Trust
Barts & The London NHS Trust
Milton Keynes University Hospital NHS Foundation Trust
Buckinghamshire Healthcare NHS Trust
Southern Health

Investigators

PRINCIPAL_INVESTIGATOR: Professor George B Hanna, PhD, FRCS, Imperial College London

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record