Surveillance of Pancreatic Health After Diabetes Diagnosis
NCT ID: NCT06803771
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15000 participants
INTERVENTIONAL
2025-05-21
2029-02-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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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.
Avantect Pancreatic Cancer Test
Avantect test
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.
Avantect Pancreatic Cancer Test
Avantect test
Interventions
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Avantect Pancreatic Cancer Test
Avantect test
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
84 Years
ALL
No
Sponsors
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ClearNote Health
INDUSTRY
University Hospital Southampton NHS Foundation Trust
OTHER
Responsible Party
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Locations
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Brockwood Medical Practice
Brockham, Surrey, United Kingdom
Integrated Care Partnership/ The Old Cottage Hospital
Epsom, Surrey, United Kingdom
Warlingham Green Medical Practice
Warlingham, Surrey, United Kingdom
Bournemouth Research Hub
Bournemouth, , United Kingdom
Willesden Medical Centre
London, , United Kingdom
South Westminster Centre
London, , United Kingdom
The Cuckoo Lane Practice
London, , United Kingdom
King's Mill Hospital (Sherwood Forest) Research Van
Nottingham, , United Kingdom
Portsmouth Research Hub
Portsmouth, , United Kingdom
Pembroke Centre (Hillingdon)
Ruislip, , United Kingdom
Southampton Research Hub (Shirley Research Hub)
Southampton, , United Kingdom
Moorgreen Hospital
Southampton, , United Kingdom
Civic Centre
Uxbridge, , United Kingdom
Weymouth Research Hub
Weymouth, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related Info
Other Identifiers
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RHMGSU0292
Identifier Type: -
Identifier Source: org_study_id
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