Monitoring pancreatic health after a new diabetes diagnosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional trial will enroll up to 15,000 people aged 50–84 with a type 2 diabetes diagnosis within the past 180 days and assign them to either immediate Avantect testing or a control arm whose samples are stored. Participants will attend three visits over 12 months to give blood and complete anxiety questionnaires, and intervention-arm participants with a positive Avantect result will be offered standard-of-care imaging (MRI or CT) to rule out pancreatic cancer. Control-arm samples will be retained for potential future Avantect testing or research, and all participants will be followed remotely through cancer and mortality registries to capture outcomes. The aim is to determine whether Avantect can identify pancreatic cancer at an earlier, more treatable stage in this higher-risk group.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 50 - 84 years of age at the time of enrolment (within year of birth, not month of birth)
* Confirmed type 2 DM diagnosis established within the last 200 days or an initial elevated HbA1c ≥ 48 mmol/mol or 6.5% obtained within the last 200 days. This includes people who have a first elevated HbA1c (≥ 48 mmol/mol or 6.5%) within the last 200 days, even if subsequent HbAc1 measurements return to the the normal range.
* Willing to provide up to 30 mL of blood for each study visit
* Willing and eligible to undergo MRI or CT scan
* 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 or an initial HbA1c ≥ 48 mmol/mol or 6.5% obtained prior to the 200-day inclusion window, except gestational elevated HbA1c.
* A history of pancreatic cancer, pancreatic neuroendocrine tumour (pNET) or Pancreatitis
* Under investigation for or confirmed pancreatic cancer
* Under investigation/surveillance for 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
* BMI \> 40 at the time of consent
* Blood transfusion within 1 month
* Solid organ transplant recipient
* Currently pregnant
* Needing dialysis

Where it's running

• Maidstone and Tunbridge Wells NHS Trust
  Maidstone, Kent, United Kingdom Recruiting
• Forest Medical Group
  Leicester, Leicester Forest East, United Kingdom Recruiting
• South Leicestershire Medical Group
  Kibworth Beauchamp, Leicestershire, United Kingdom Recruiting
• Peel Croft Surgery
  Burton-on-Trent, Staffordshire, United Kingdom Recruiting
• Kingswinford Medical Practice
  Kingswinford, Staffordshire, United Kingdom Recruiting
• Park Medical Centre
  Leek, Staffordshire, United Kingdom Recruiting

Study contacts

• Study coordinator: SAFE-D Trial Manager
• Email: safed@soton.ac.uk
• Phone: +442381205154

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.