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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15000 (estimated) |
| Ages | 50 Years to 84 Years |
| Sex | All |
| Sponsor | University Hospital Southampton NHS Foundation Trust (other) |
| Locations | 31 sites (Sandbach, Cheshire and 30 other locations) |
| Trial ID | NCT06803771 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
- Ashfields Primary Care Centre — Sandbach, Cheshire, United Kingdom (RECRUITING)
- Maidstone and Tunbridge Wells NHS Trust — Maidstone, Kent, United Kingdom (RECRUITING)
- Balance Street Health Centre — Uttoxeter, 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)
- Trinity Court Surgery — Stratford-upon-Avon, Staffordshire, United Kingdom (RECRUITING)
- Brockwood Medical Practice — Brockham, Surrey, United Kingdom (RECRUITING)
- Integrated Care Partnership/ The Old Cottage Hospital — Epsom, Surrey, United Kingdom (RECRUITING)
- Warlingham Green Medical Practice — Warlingham, Surrey, United Kingdom (RECRUITING)
- Ashton Medical Group — Ashton-under-Lyne, United Kingdom (RECRUITING)
- Yardley Wood Health Centre — Birmingham, United Kingdom (RECRUITING)
- Bournemouth Research Hub — Bournemouth, United Kingdom (RECRUITING)
- Eastham Group Practice — Bromborough, United Kingdom (RECRUITING)
- Willesden Medical Centre — London, United Kingdom (RECRUITING)
- South Westminster Centre — London, United Kingdom (RECRUITING)
- The Cuckoo Lane Practice — London, United Kingdom (RECRUITING)
- Bodey Medical Centre — Manchester, United Kingdom (RECRUITING)
- Bowland Medical Practice — Manchester, United Kingdom (RECRUITING)
- The Maples Medical Centre — Manchester, United Kingdom (RECRUITING)
- King's Mill Hospital (Sherwood Forest) Research Van — Nottingham, United Kingdom (RECRUITING)
- Portsmouth Research Hub — Portsmouth, United Kingdom (RECRUITING)
- Hazelvalley Family Practice — Rossendale, United Kingdom (RECRUITING)
- Pembroke Centre (Hillingdon) — Ruislip, United Kingdom (RECRUITING)
- Southampton Research Hub (Shirley Research Hub) — Southampton, United Kingdom (RECRUITING)
- Moorgreen Hospital — Southampton, United Kingdom (RECRUITING)
- Civic Centre — Uxbridge, United Kingdom (RECRUITING)
- Quinton Practice — Walsall, United Kingdom (RECRUITING)
- Weymouth Research Hub — Weymouth, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: SAFE-D Trial Manager
- Email: safed@soton.ac.uk
- Phone: +442381205154
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus, Pancreatic Cancer, Adult, Type 2 diabetes, pancreatic cancer