Volatile Organic Compound Assessment in Pancreatic Ductal Adenocarcinoma

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.

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