RecruitingNCT05727020

Volatile Organic Compound Assessment in Pancreatic Ductal Adenocarcinoma

Volatile Organic Compound Assessment in Pancreatic Ductal Adenocarcinoma (VAPOR 1 / BIORESOURCE)


Sponsor

Imperial College London

Enrollment

1,005 participants

Start Date

Dec 15, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria8

  • 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

Interventions

DIAGNOSTIC_TESTBreath test

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.

DIAGNOSTIC_TESTCollection of matched samples of breath, biofluids and pancreatic tissue

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.


Locations(1)

Imperial College Healthcare NHS Trust

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05727020


Related Trials