Surveillance of Pancreatic Health After Diabetes Diagnosis (SAFE-D)

March 20, 2026 updated by: University Hospital Southampton NHS Foundation Trust

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

15000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Ashton-under-Lyne, United Kingdom, OL6 6HD
        • Recruiting
        • Ashton Medical Group
        • Contact:
      • Birmingham, United Kingdom, B14 4DU
        • Recruiting
        • Yardley Wood Health Centre
        • Contact:
      • Bournemouth, United Kingdom, BH7 7DW
        • Recruiting
        • Bournemouth Research Hub
        • Contact:
      • Bromborough, United Kingdom, CH62 6EE
        • Recruiting
        • Eastham Group Practice
        • Contact:
      • London, United Kingdom, NW10 2PT
        • Recruiting
        • Willesden Medical Centre
        • Contact:
      • London, United Kingdom, SW1P 2PF
        • Recruiting
        • South Westminster Centre
        • Contact:
      • London, United Kingdom, W7 1DR
        • Recruiting
        • The Cuckoo Lane Practice
        • Contact:
      • Manchester, United Kingdom, M14 6WP
        • Recruiting
        • Bodey Medical Centre
        • Contact:
      • Manchester, United Kingdom, M23 1JX
        • Recruiting
        • Bowland Medical Practice
        • Contact:
      • Manchester, United Kingdom, M23 2SY
        • Recruiting
        • The Maples Medical Centre
        • Contact:
      • Nottingham, United Kingdom, NG17 4JL
        • Recruiting
        • King's Mill Hospital (Sherwood Forest) Research Van
        • Contact:
      • Portsmouth, United Kingdom, PO1 3HN
        • Recruiting
        • Portsmouth Research Hub
        • Contact:
      • Rossendale, United Kingdom, BB4 5SL
        • Recruiting
        • Hazelvalley Family Practice
        • Contact:
      • Ruislip, United Kingdom, HA4 8NX
        • Recruiting
        • Pembroke Centre (Hillingdon)
        • Contact:
      • Southampton, United Kingdom, SO30 3JB
        • Recruiting
        • Moorgreen Hospital
        • Contact:
      • Southampton, United Kingdom, SO15 33UA
        • Recruiting
        • Southampton Research Hub (Shirley Research Hub)
        • Contact:
      • Uxbridge, United Kingdom, UB8 1UW
        • Recruiting
        • Civic Centre
        • Contact:
      • Walsall, United Kingdom, WS6 6EW
        • Recruiting
        • Quinton Practice
        • Contact:
      • Weymouth, United Kingdom, DT4 0QE
        • Recruiting
        • Weymouth Research Hub
        • Contact:
    • Cheshire
      • Sandbach, Cheshire, United Kingdom, CW11 1EQ
        • Recruiting
        • Ashfields Primary Care Centre
        • Contact:
    • Kent
      • Maidstone, Kent, United Kingdom, ME16 9QQ
        • Recruiting
        • Maidstone and Tunbridge Wells NHS Trust
        • Contact:
      • Uttoxeter, Kent, United Kingdom, ST14 8JG
        • Recruiting
        • Balance Street Health Centre
        • Contact:
    • Leicester Forest East
      • Leicester, Leicester Forest East, United Kingdom, LE3 3LW
        • Recruiting
        • Forest Medical Group
        • Contact:
    • Leicestershire
      • Kibworth Beauchamp, Leicestershire, United Kingdom, LE8 0LG
        • Recruiting
        • South Leicestershire Medical Group
        • Contact:
    • Staffordshire
      • Burton-on-Trent, Staffordshire, United Kingdom, DE14 3RH
        • Recruiting
        • Peel Croft Surgery
        • Contact:
      • Kingswinford, Staffordshire, United Kingdom, DY6 8DN
        • Recruiting
        • Kingswinford Medical Practice
        • Contact:
      • Leek, Staffordshire, United Kingdom, ST13 6QR
        • Recruiting
        • Park Medical Centre
        • Contact:
      • Stratford-upon-Avon, Staffordshire, United Kingdom, CV37 6HJ
        • Recruiting
        • Trinity Court Surgery
        • Contact:
    • Surrey
      • Brockham, Surrey, United Kingdom, RH3 7NJ
        • Recruiting
        • Brockwood Medical Practice
        • Contact:
      • Epsom, Surrey, United Kingdom, KT17 4BL
        • Recruiting
        • Integrated Care Partnership/ The Old Cottage Hospital
        • Contact:
      • Warlingham, Surrey, United Kingdom, CR6 9NW
        • Recruiting
        • Warlingham Green Medical Practice
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
Participants 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.
Device: Avantect Pancreatic Cancer Test
Avantect test
Placebo Comparator: Control Arm (Standard of Care [SoC] arm)
Control 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.
Device: Avantect Pancreatic Cancer Test
Avantect test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of the Avantect test
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stage shift
Time Frame: 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.
The proportion of pancreatic cancers cases diagnosed at stage I/II vs III/IV between the intervention and control arms. A proportion of 60% (44/73 PCs) is expected in the intervention arm versus 35% (26/73 PCs) in the control arm, which provides 90% power at a one-sided alpha of 0.05. Stage shift will be considered successful if the proportion in the intervention arm is higher than the rate in the control arm at a one-sided p-value of 0.05.
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)
Time Frame: 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.
Percentage of participants with an Avantect "detected" result who have pancreatic cancer diagnosed. The analysis will be conducted within the intervention arm. With a sample size of 7,500, PC prevalence of 1%, and 2.5% lost from the per protocol population, there will be an expected 410 individuals with an Avantect "detected - abnormal" result. 11.6% (48/410) are expected to have a PC. PPV will be considered successful if a null PPV of 5% can be ruled out at a one-sided p-value of 0.05.
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)
Time Frame: 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.
Percentage of participants with no Avantect "detected" test result who have no diagnosis of pancreatic cancer. The analysis will be conducted within the intervention arm with a sample size of 7,500, PC prevalence of 1%, and 2.5% lost from the per protocol population, will be an expected 6,902 individuals without an Avantect "detected - abnormal" result. 99.6% (6,877/6,902) are expected to not have a diagnosis of PC. NPV will be considered successful if a null NPV of 99% can be ruled out at a one-sided p-value of 0.05.
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
Time Frame: 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.
Percentage of participants with pancreatic cancer who underwent resection. The analysis will be conducted by comparing resection between the intervention and control arms. With a sample size of 15,000, PC prevalence of 1%, and 2.5% lost to follow-up, there will be an expected 73 cases of PC in each arm. It is assumed that 5% of those deemed resectable will not undergo resection, for an expected rate of 38% (28/73) in the Intervention arm versus 13% (9/73) in the control arm. Resection rate will be considered successful if the proportion in the intervention arm is higher than the rate in the control arm at a one-sided p-value of 0.05.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-to-event outcomes
Time Frame: 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.
To estimate the time from new onset diabetes diagnosis to pancreatic cancer diagnosis. This will be analysed within intervention arm.
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
Time Frame: 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.
To estimate the overall survival of study participants. This will be compared between intervention and control arm.
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
Time Frame: 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.
To assess the effect of the Avantect test on state anxiety over time. This will be compared between intervention and control arm.
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.
High-grade neoplasia
Time Frame: 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.
To investigate the performance characteristics for high-grade neoplasia. This will be analysed within intervention arm.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Southampton NHS Foundation Trust

Collaborators

ClearNote Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2025

Primary Completion (Estimated)

February 28, 2028

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

January 31, 2025

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHMGSU0292

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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