At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Breath test (diagnostic test), Collection of matched samples of breath, biofluids and pancreatic tissue (diagnostic test)
- How long the study runs
- Study runs about 68 months (dates as stated)
- About the drug or intervention
- Breath test — diagnostic test: Patients must be fasted for a minimum of six hours prior to sample collection. · Collection of matched samples of breath, biofluids and pancreatic tissue — diagnostic test: In accordance with routine clinical practices, patients will be fasted for a minimum of six hours prior to surgery.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,005
- Started
- 2022-12-15
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for pdac - pancreatic ductal adenocarcinoma
- • Clinical study - 1,005 participants
- • Patients with early pancreatic cancer often have symptoms that could also be caused by many common benign conditions, or no symptoms at all
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with pdac - pancreatic ductal adenocarcinoma
Where?
- • London - Imperial College Healthcare NHS Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
More detail
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: 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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Males and females
- ✓Adult patients ≥ 18 years old
- ✓Note: \*Patients undergoing surgery for suspected PDAC (without pre-operative histological confirmation) may be...
Who cannot take part
- ✗Patients who have already received drug treatment, 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
See the full criteria
Where Is This Study? (1 UK site)
Imperial College Healthcare NHS Trust
London, United Kingdom
How to Get in Touch
Miss Caoimhe M Walsh, MBBS, MRCS
Sponsor contactCONTACT
Emma Austin
Sponsor contactCONTACT