Surveillance of Pancreatic Health After Diabetes Diagnosis
SAFE-D
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
1 other identifier
interventional
15,000
1 country
31
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 months. Participants will:
- attend 3 study visits over 12 months time
- provide a blood sample at each study visit
- complete an anxiety questionnaire at each visit.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus
Started May 2025
Longer than P75 for not_applicable diabetes-mellitus
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2025
CompletedFirst Posted
Study publicly available on registry
January 31, 2025
CompletedStudy Start
First participant enrolled
May 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2029
March 23, 2026
August 1, 2025
2.8 years
January 27, 2025
March 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Sensitivity of the Avantect test
The proportion of participants in the intervention arm with one (or more) Avantect "detected" test result who have pancreatic cancer diagnosed via imging in relation to all individuals in the intervention arm who had pancreatic cancer diagnosed.
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
The proportion of participants in the intervention arm with one or more Avantect "not detected" test results, and no Avantect "detected" results, who did not have a pancreatic cancer diagnosis in relation to all individuals in the intervention arm who did not have a pancreatic cancer diagnosis.
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
The proportion of pancreatic cancers deemed resectable by the study MDT divided by the number of pancreatic cancers and will be compared between arms.
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.
Secondary Outcomes (4)
Stage shift
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.
Positive Predictive Value (PPV) of Avantect test in detecting pancreatic cancer (PC)
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.
Negative Predictive Value (NPV) of Avantect test in ruling out pancreatic cancer (PC)
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.
Resection 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.
Other Outcomes (4)
Time-to-event outcomes
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.
Overall survival
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.
Effect of the Avantect test on state anxiety over time
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.
- +1 more other outcomes
Study Arms (2)
Intervention Arm
EXPERIMENTALParticipants in the intervention Arm will have their blood samples tested on the Avantect test within prioritised timeframe. The "detected" Avantect test results will be shared with the participants and their General Practitioners (GPs) to allow for further MRI or CT investigations by the local clinical team.
Control Arm (Standard of Care [SoC] arm)
PLACEBO COMPARATORControl arm participants will have their blood samples collected but they will not be tested on the Avantect test. Participants will receive the current standard of care for diabetes management. Blood samples will be used for potential future Avantect testing and/ or future research.
Interventions
Avantect test
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Ashfields Primary Care Centre
Sandbach, Cheshire, CW11 1EQ, United Kingdom
Maidstone and Tunbridge Wells NHS Trust
Maidstone, Kent, ME16 9QQ, United Kingdom
Balance Street Health Centre
Uttoxeter, Kent, ST14 8JG, United Kingdom
Forest Medical Group
Leicester, Leicester Forest East, LE3 3LW, United Kingdom
South Leicestershire Medical Group
Kibworth Beauchamp, Leicestershire, LE8 0LG, United Kingdom
Peel Croft Surgery
Burton-on-Trent, Staffordshire, DE14 3RH, United Kingdom
Kingswinford Medical Practice
Kingswinford, Staffordshire, DY6 8DN, United Kingdom
Park Medical Centre
Leek, Staffordshire, ST13 6QR, United Kingdom
Trinity Court Surgery
Stratford-upon-Avon, Staffordshire, CV37 6HJ, United Kingdom
Brockwood Medical Practice
Brockham, Surrey, RH3 7NJ, United Kingdom
Integrated Care Partnership/ The Old Cottage Hospital
Epsom, Surrey, KT17 4BL, United Kingdom
Warlingham Green Medical Practice
Warlingham, Surrey, CR6 9NW, United Kingdom
Ashton Medical Group
Ashton-under-Lyne, OL6 6HD, United Kingdom
Yardley Wood Health Centre
Birmingham, B14 4DU, United Kingdom
Bournemouth Research Hub
Bournemouth, BH7 7DW, United Kingdom
Eastham Group Practice
Bromborough, CH62 6EE, United Kingdom
Willesden Medical Centre
London, NW10 2PT, United Kingdom
South Westminster Centre
London, SW1P 2PF, United Kingdom
The Cuckoo Lane Practice
London, W7 1DR, United Kingdom
Bodey Medical Centre
Manchester, M14 6WP, United Kingdom
Bowland Medical Practice
Manchester, M23 1JX, United Kingdom
The Maples Medical Centre
Manchester, M23 2SY, United Kingdom
King's Mill Hospital (Sherwood Forest) Research Van
Nottingham, NG17 4JL, United Kingdom
Portsmouth Research Hub
Portsmouth, PO1 3HN, United Kingdom
Hazelvalley Family Practice
Rossendale, BB4 5SL, United Kingdom
Pembroke Centre (Hillingdon)
Ruislip, HA4 8NX, United Kingdom
Southampton Research Hub (Shirley Research Hub)
Southampton, SO15 33UA, United Kingdom
Moorgreen Hospital
Southampton, SO30 3JB, United Kingdom
Civic Centre
Uxbridge, UB8 1UW, United Kingdom
Quinton Practice
Walsall, WS6 6EW, United Kingdom
Weymouth Research Hub
Weymouth, DT4 0QE, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2025
First Posted
January 31, 2025
Study Start
May 21, 2025
Primary Completion (Estimated)
February 28, 2028
Study Completion (Estimated)
February 1, 2029
Last Updated
March 23, 2026
Record last verified: 2025-08