Breath test for early detection of pancreatic cancer
Volatile Organic Compound Assessment in Pancreatic Ductal Adenocarcinoma (VAPOR 1 / BIORESOURCE)
This study is testing a new breath test to see if it can help find pancreatic cancer earlier in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1005 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (London) |
| Trial ID | NCT05727020 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve the early detection of pancreatic ductal adenocarcinoma (PDAC) by developing a non-invasive breath test that identifies volatile organic compounds (VOCs) associated with the disease. A total of 192 patients will provide samples for a pancreatic biobank, while an additional 771 patients will participate in the VAPOR 1 clinical study to validate the breath test. The study will analyze various biosamples, including breath, saliva, blood, and pancreatic tissue, to understand the mechanisms of VOC production in PDAC. The goal is to enable quicker diagnosis and treatment for patients with pancreatic cancer.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed PDAC, new-onset diabetes mellitus, chronic pancreatitis, or non-specific gastrointestinal symptoms with a radiologically-normal pancreas.
Not a fit: Patients who have previously received chemotherapy, radiotherapy, or surgery for their PDAC, as well as those unable to provide a breath sample, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of pancreatic cancer, improving treatment options and survival rates for patients.
How similar studies have performed: While the approach of using breath analysis for cancer detection is promising, this specific methodology is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion 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 * 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
Where this trial is running
London
- Imperial College Healthcare NHS Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Professor George B Hanna, PhD, FRCS — Imperial College London
- Study coordinator: Miss Caoimhe M Walsh, MBBS, MRCS
- Email: vapor@imperial.ac.uk
- Phone: +44 (0)20 7594 3653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.