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Surveillance of Pancreatic Health After Diabetes Diagnosis

NCT06803771 · University Hospital Southampton NHS Foundation Trust
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Official title
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
About this study
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 treatment options. Early detection offers the possibility of surgery leading to significantly improved overall survival. There is currently no accepted screening test for pancreatic cancer. The Aventect test is designed to detect clues, or biomarkers for the presence or absence of pancreatic cancer signals in blood. The SAFE-D study will evaluate if the Avantect test can detect pancreatic cancer at an earlier more treatable stage. People older than 50 years who have recently been diagnosed with type II diabetes have up to ten times higher-than-average risk of having pancreatic cancer without knowing. The study will recruit up to 15,000 participants aged 50-84 years old diagnosed with type II diabetes within the last 6 months from GP practices over 3 years. Participants will be randomly assigned to either the active intervention arm or the control arm for comparison. Intervention arm samples will be run on the Avantect test as soon as possible. If a pancreatic biomarker is detected the participants will be informed and offered a standard of care diagnostic imaging scan (MRI or CT) to rule out pancreatic cancer. Control arm samples will be stored for potential future Avantect testing or future research. All participants will be followed remotely via cancer and mortality registry searches for 3 years from consent to assess any cancer diagnosed during this time.
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
Study design
Enrollment target: 15000 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-05-21
Estimated completion: 2029-02
Last updated: 2026-03-23
Interventions
Device: Avantect Pancreatic Cancer Test
Primary outcomes
  • Sensitivity of the Avantect test (Stage 1 analysis will be carried out 6 months after the T1 visit for 3,200 participants in the intervention arm. Stage 2 analysis will be carried out after 3-year follow-up data has been collected for all 15,000 participants.)
  • Specificity of the Avantect test (Stage 1 analysis will be carried out 6 months after the T1 visit for 3,200 participants in the intervention arm. Stage 2 analysis will be carried out after 3-year follow-up data has been collected for all 15,000 participants.)
  • Resectability rate of pancreatic cancer (Stage 1 analysis will be carried out 6 months after the T1 visit for 3,200 participants in the intervention arm. Stage 2 analysis will be carried out after 3-year follow-up data has been collected for all 15,000 participants.)
Sponsor
University Hospital Southampton NHS Foundation Trust · other
With: ClearNote Health
Contacts & investigators
ContactSAFE-D Trial Manager · contact · safed@soton.ac.uk · +442381205154
All locations (31)
Ashfields Primary Care CentreRecruiting
Sandbach, Cheshire, United Kingdom
Maidstone and Tunbridge Wells NHS TrustRecruiting
Maidstone, Kent, United Kingdom
Balance Street Health CentreRecruiting
Uttoxeter, Kent, United Kingdom
Forest Medical GroupRecruiting
Leicester, Leicester Forest East, United Kingdom
South Leicestershire Medical GroupRecruiting
Kibworth Beauchamp, Leicestershire, United Kingdom
Peel Croft SurgeryRecruiting
Burton-on-Trent, Staffordshire, United Kingdom
Kingswinford Medical PracticeRecruiting
Kingswinford, Staffordshire, United Kingdom
Park Medical CentreRecruiting
Leek, Staffordshire, United Kingdom
Trinity Court SurgeryRecruiting
Stratford-upon-Avon, Staffordshire, United Kingdom
Brockwood Medical PracticeRecruiting
Brockham, Surrey, United Kingdom
Integrated Care Partnership/ The Old Cottage HospitalRecruiting
Epsom, Surrey, United Kingdom
Warlingham Green Medical PracticeRecruiting
Warlingham, Surrey, United Kingdom
Ashton Medical GroupRecruiting
Ashton-under-Lyne, United Kingdom
Yardley Wood Health CentreRecruiting
Birmingham, United Kingdom
Bournemouth Research HubRecruiting
Bournemouth, United Kingdom
Eastham Group PracticeRecruiting
Bromborough, United Kingdom
Willesden Medical CentreRecruiting
London, United Kingdom
South Westminster CentreRecruiting
London, United Kingdom
The Cuckoo Lane PracticeRecruiting
London, United Kingdom
Bodey Medical CentreRecruiting
Manchester, United Kingdom
Bowland Medical PracticeRecruiting
Manchester, United Kingdom
The Maples Medical CentreRecruiting
Manchester, United Kingdom
King's Mill Hospital (Sherwood Forest) Research VanRecruiting
Nottingham, United Kingdom
Portsmouth Research HubRecruiting
Portsmouth, United Kingdom
Hazelvalley Family PracticeRecruiting
Rossendale, United Kingdom
Pembroke Centre (Hillingdon)Recruiting
Ruislip, United Kingdom
Southampton Research Hub (Shirley Research Hub)Recruiting
Southampton, United Kingdom
Moorgreen HospitalRecruiting
Southampton, United Kingdom
Civic CentreRecruiting
Uxbridge, United Kingdom
Quinton PracticeRecruiting
Walsall, United Kingdom
Weymouth Research HubRecruiting
Weymouth, United Kingdom
Surveillance of Pancreatic Health After Diabetes Diagnosis · TrialPath