Trial Title:
Volatile Organic Compound Assessment in Pancreatic Ductal Adenocarcinoma
NCT ID:
NCT05727020
Condition:
PDAC - Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer
Conditions: Official terms:
Adenocarcinoma
Conditions: Keywords:
Volatile organic compounds (VOCs)
Breath analysis
Volatolomics
Metabonomics / Lipidomics
Transcriptomics
Microbiome Analysis
Organoids
Immune profiling
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Breath test
Description:
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.
Arm group label:
VAPOR 1 - Control patients with benign pancreatic disorders
Arm group label:
VAPOR 1 - Control patients with non-specific GI symptoms and a normal pancreas
Arm group label:
VAPOR 1 - PDAC (pancreatic ductal adenocarcinoma)
Intervention type:
Diagnostic Test
Intervention name:
Collection of matched samples of breath, biofluids and pancreatic tissue
Description:
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.
Arm group label:
VAPOR Bioresource - Control patients with benign pancreatic disorders
Arm group label:
VAPOR Bioresource - PDAC (pancreatic ductal adenocarcinoma)
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.
Detailed description:
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.
Criteria for eligibility:
Study pop:
Patients seen in a hospital (secondary or tertiary level care) setting
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients who have already received chemotherapy, radiotherapy or surgery for their
PDAC
- Patients with active infection, receiving immunosuppressive medications or
antibiotics within the preceding eight weeks
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Imperial College Healthcare NHS Trust
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
VAPOR Trial Manager
Start date:
December 15, 2022
Completion date:
January 2025
Lead sponsor:
Agency:
Imperial College London
Agency class:
Other
Collaborator:
Agency:
Pancreatic Cancer UK
Agency class:
Other
Collaborator:
Agency:
Imperial College Healthcare NHS Trust
Agency class:
Other
Collaborator:
Agency:
Royal Free Hospital NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
Liverpool University Hospitals NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
The Leeds Teaching Hospitals NHS Trust
Agency class:
Other
Collaborator:
Agency:
Sheffield Teaching Hospitals NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
University Hospital Southampton NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
Royal Surrey County Hospital NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
University Hospital Birmingham NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
Manchester University NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
Newcastle-upon-Tyne Hospitals NHS Trust
Agency class:
Other
Source:
Imperial College London
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05727020
