Monitoring pancreatic health after a new diabetes diagnosis

A Randomised Trial to Evaluate the cfDNA Pancreatic Cancer Test (Avantect) in the Early Detection of Pancreatic Cancer in Patients With Newly Diagnosed Diabetes Mellitus

NA · University Hospital Southampton NHS Foundation Trust · NCT06803771

We will try a new blood test called Avantect to see if it can detect early pancreatic cancer in people aged 50–84 who were diagnosed with type 2 diabetes within the past six months.

Quick facts

PhaseNA
Study typeInterventional
Enrollment15000 (estimated)
Ages50 Years to 84 Years
SexAll
SponsorUniversity Hospital Southampton NHS Foundation Trust (other)
Locations31 sites (Sandbach, Cheshire and 30 other locations)
Trial IDNCT06803771 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: People aged 50–84 diagnosed with type 2 diabetes within the last 180 days who can provide blood samples and are able to undergo MRI (or CT if MRI is contraindicated) are ideal candidates.

Not a fit: People diagnosed with diabetes more than six months ago, those with prior pancreatic disease or recent invasive cancers, or participants randomized to the control arm may not receive direct, immediate benefit from the test.

Why it matters

Potential benefit: If successful, Avantect could find pancreatic cancer earlier in people with new-onset type 2 diabetes, potentially enabling earlier treatment and improved survival.

How similar studies have performed: Blood-based biomarker screening in new-onset diabetes is an active area of research with promising signals, but there is not yet a widely accepted, validated clinical test for pancreatic cancer screening.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Sandbach, Cheshire and 30 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Diabetes Mellitus, Pancreatic Cancer, Adult, Type 2 diabetes, pancreatic cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.