Volatile Organic Compound Assessment in Pancreatic Ductal Adenocarcinoma
Recruiting · NCT05727020 · Observational (researchers observe without assigning treatment) · Lead sponsor: Imperial College London
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
1 location listed.
- Imperial College Healthcare NHS Trust - London, United Kingdom