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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
United Kingdom
Imperial College Healthcare NHS Trust
RECRUITING
London
Contact Information
Primary
Miss Caoimhe M Walsh, MBBS, MRCS
vapor@imperial.ac.uk
+44 (0)20 7594 3653
Backup
Emma Austin
vapor@imperial.ac.uk
+44 (0)20 7594 3653
Time Frame
Start Date: 2022-12-15
Estimated Completion Date: 2026-04
Participants
Target number of participants: 1005
Treatments
VAPOR 1 - PDAC (pancreatic ductal adenocarcinoma)
304 treatment-naive patients with histologically-confirmed\* PDAC will be recruited to provide breath samples.~\*Patients that are due to undergo surgery for suspected PDAC (without pre-operative histological confirmation) may still be recruited despite the lack of pre-operative histological confirmation, assuming PDAC is subsequently confirmed within the resected specimen.
VAPOR 1 - Control patients with benign pancreatic disorders
257 patients with new-onset diabetes mellitus or chronic pancreatitis will be recruited to provide breath samples.~New-onset diabetes is defined as: HbA1c≥48mmol/mol (6.5%), diagnosed within the preceding 6 months.
VAPOR 1 - Control patients with non-specific GI symptoms and a normal pancreas
257 patients with non-specific gastrointestinal symptoms but a radiologically-normal pancreas will be recruited to provide breath samples.~Imaging to confirm a normal pancreas (CT / MRI / ultrasound) must have occurred within the preceding 12 months.
VAPOR Bioresource - PDAC (pancreatic ductal adenocarcinoma)
96 treatment-naive patients with histologically-confirmed\* PDAC will be recruited to provide samples of breath, saliva, blood, urine, pancreatic tissue and duodenal aspirate.~\*Patients that are due to undergo surgery for suspected PDAC (without pre-operative histological confirmation) may still be recruited despite the lack of pre-operative histological confirmation, assuming PDAC is subsequently confirmed within the resected specimen.
VAPOR Bioresource - Control patients with benign pancreatic disorders
96 patients with benign pancreatic disorders (such as intraductal papillary mucinous neoplasms, pancreatic mucinous cystic neoplasms, chronic pancreatitis) will be recruited to provide samples of breath, saliva, blood, urine, pancreatic tissue and duodenal aspirate.
Sponsors
Collaborators: Newcastle-upon-Tyne Hospitals NHS Trust, Royal Free Hospital NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, Barts & The London NHS Trust, Milton Keynes University Hospital NHS Foundation Trust, Buckinghamshire Healthcare NHS Trust, University Hospital Southampton NHS Foundation Trust, Sheffield Teaching Hospitals NHS Foundation Trust, University Hospital Birmingham NHS Foundation Trust, North Tees and Hartlepool NHS Foundation Trust, Imperial College Healthcare NHS Trust, Dorset County Hospital NHS Foundation Trust, Liverpool University Hospitals NHS Foundation Trust, Southern Health, Swansea Bay University Health Board, Manchester University NHS Foundation Trust, Royal Surrey County Hospital NHS Foundation Trust, Pancreatic Cancer UK, University Hospital Plymouth NHS Trust
Leads: Imperial College London

This content was sourced from clinicaltrials.gov