Diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
This is a prospective, single-blinded interventional randomised multicentre study. Blood samples will be collected at three separate timepoints over 12 months to evaluate the Avantect pancreatic cance
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
50 Years to 84 Years
Inclusion criteria
Inclusion criteria: 1. 50 – 84 years of age at the time of enrolment (within a year of birth, not month of birth) 2. Haemoglobin A1c (HbA1c) >=48 or 6.5% and/or confirmed type II DM diagnosed within the last 180 days (+20 days flexibility allowance) 3. Willing to provide up to 30 mL of blood for each study visit 4. Willing and eligible to undergo MRI scan (or CT scan if MRI is contraindicated) 5. Understands the study process and is willing to take part in the study and sign the informed consent form
Exclusion criteria
Exclusion criteria: 1. Prior type I or type II DM diagnosis >6 months 2. A history of pancreatic cancer, pancreatic neuroendocrine tumour (pNET) or Pancreatitis 3. Under investigation for pancreatic cancer/ pancreatic cyst 4. Any known pancreatic surgery (not including ERCP), or other major surgery requiring anaesthesia within 3 months 5. Any invasive solid or haematological cancer in the past 3 years, including cancer recurrence after treatment in the last 3 years 6. Current chronic or acute oral or systemic steroid use within 3 months of initial HbA1c or diabetes diagnosis (estimate rather than accurate) 7. Blood transfusion within 1 month 8. Solid organ transplant recipient 9. Currently pregnant 10. Needing dialysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The sensitivity of the Avantect test in detecting PC is measured as the percentage of participants with PC diagnosed who have an Avantect “detected” result (within the intervention arm) at 6 months after T1, and after 3-year follow-up data has been collected for all participants. 2. Specificity of the Avantect test in ruling out PC is measured as the percentage of participants without PC diagnosed who have one or more Avantect “not detected” results and no Avantect “detected” results (within the intervention arm) at 6 months after T1, and after 3-year follow-up data has been collected for all participants. 3. The resectability rate of PC is measured as the percentage of PCs deemed resectable by the study MDT (compared between arms) at 6 months after T1, and after 3-year follow-up data has been collected for all participants. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pancreatic cancer stage shift is measured as the percentage of PCs diagnosed at stage I/II (compared between arms) at 6 months after T1, and after 3-year follow-up data has been collected for all participants. 2. Positive Predictive Value (PPV) of the Avantect test for detecting PC is measured as the percentage of individuals with an Avantect “detected” result who have PC diagnosed (within the intervention arm) at 6 months after T1, and after 3-year follow-up data has been collected for all participants. 3. Negative Predictive Value (NPV) of the Avantect test for ruling out PC is measured as the percentage of individuals with no Avantect “detected” test results who have no diagnosis of PC (within the intervention arm) at 6 months after T1, and after 3-year follow-up data has been collected for all participants. 4. Resection of PC is measured as the percentage of individuals with PC who underwent resection (compared between arms) at 6 months after T1, and after 3-year follow-up data has been collected for all participants. | — |
Countries
England, United Kingdom
Contacts
Public ContactKasia Anson-Wisniewska
Outcome results
None listed