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NCT05727020
Volatile Organic Compound Assessment in Pancreatic Ductal Adenocarcinoma
Conditions: PDAC - Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Enrollment: 963
Sponsor: Imperial College London
Location: United Kingdom
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 Criteria
Inclusion Criteria:Males and femalesAdult patients ≥ 18 years oldVAPOR 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 pancreasVAPOR 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 pancreatitisNote: *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 PDACPatients with active infection, receiving immunosuppressive medications or antibiotics within the preceding eight weeksHistory of another cancer within the previous five yearsPrevious upper gastrointestinal surgeryPatients who are unable to provide a breath samplePregnant womenPatients unable to provide informed written consent
Source: ClinicalTrials.gov (NCT05727020). StuddyBuddy aggregates publicly available trial information.