Status:
RECRUITING
Surveillance of Pancreatic Health After Diabetes Diagnosis
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust
Collaborating Sponsors:
ClearNote Health
Conditions:
Diabetes Mellitus
Pancreatic Cancer, Adult
Eligibility:
All Genders
50-84 years
Phase:
NA
Brief Summary
The goal of this interventional study is to evaluate if the novel diagnostic blood test, called Avantect can early detect pancreatic cancer in patients diagnosed with type 2 diabetes within the last 6...
Detailed Description
Pancreatic cancer (PC) is one of the most lethal common cancers (five-year survival 5-7%). In more than 80% of patients the disease has spread before it is detected, ruling out potentially curative tr...
Eligibility Criteria
Inclusion Criteria:
- 50 - 84 years of age at the time of enrolment (within year of birth, not month of birth)
- Haemoglobin A1c (HbA1c) ≥ 48 or 6.5% and/or confirmed type II DM diagnosed within the last 180 days (+20 days flexibility allowance)
- Willing to provide up to 30 mL of blood for each study visit
- Willing and eligible to undergo MRI scan (or CT scan if MRI is contraindicated)
- Understands the study process and is willing to take part in the study and sign the informed consent form
Exclusion Criteria:
- Prior type I or type II DM diagnosis > 6 months
- A history of pancreatic cancer, pancreatic neuroendocrine tumour (pNET) or Pancreatitis
- Under investigation for pancreatic cancer / pancreatic cyst
- Any known pancreatic surgery (not including ERCP), or other major surgery requiring anaesthesia within 3 months
- Any invasive solid or haematological cancer in the past 3 years, including cancer recurrence after treatment in the last 3 years
- Current chronic or acute oral or systemic steroid use within 3 months of initial HbA1c or diabetes diagnosis (estimate rather than accurate)
- Blood transfusion within 1 month
- Solid organ transplant recipient
- Currently pregnant
- Needing dialysis
Key Trial Info
Start Date :
May 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2029
Estimated Enrollment :
15000 Patients enrolled
Trial Details
Trial ID
NCT06803771
Start Date
May 21 2025
End Date
February 1 2029
Last Update
March 23 2026
Active Locations (31)
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1
Ashfields Primary Care Centre
Sandbach, Cheshire, United Kingdom, CW11 1EQ
2
Maidstone and Tunbridge Wells NHS Trust
Maidstone, Kent, United Kingdom, ME16 9QQ
3
Balance Street Health Centre
Uttoxeter, Kent, United Kingdom, ST14 8JG
4
Forest Medical Group
Leicester, Leicester Forest East, United Kingdom, LE3 3LW