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Surveillance of Pancreatic Health After Diabetes Diagnosis

Sponsor: University Hospital Southampton NHS Foundation Trust

NCT ID: NCT06803771

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Avantect Pancreatic Cancer Test (device)
How long the study runs
Study runs about 86 months (dates as stated)
About the drug or intervention
Avantect Pancreatic Cancer Test — device: Avantect test
Patient visit burden
"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." (as stated by sponsor)
Type of study
Testing a treatment
Ages
50 Years to 84 Years
Who
All
Number of participants
5,000
Started
2025-05-21
Last checked
2026-03

Plain English Summary

What is this study?

  • • Testing a new treatment for diabetes mellitus
  • • NA - 5,000 participants
  • • 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 or with elevated sugar levels within the last 200 days

Who can take part?

  • • Ages 50 Years to 84 Years
  • • Diagnosed with diabetes mellitus

Where?

  • • Sandbach - Ashfields Primary Care Centre
  • • Maidstone - Maidstone and Tunbridge Wells NHS Trust
  • • Leicester - Forest Medical Group
  • • Kibworth Beauchamp - South Leicestershire Medical Group
  • • +27 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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 or with elevated sugar levels within the last 200 days. 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.

More detail

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 5,000 participants aged 50-84 years old diagnosed with type II diabetes or elevated Hb1Ac levels within the last 200 days from GP practices over 3 years. Participants will have their blood samples analysed 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. 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.

Diabetes MellitusPancreatic Cancer, Adult

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 50 Years - 84 Years
  • Who can join: All genders

What the study is looking for

  • ✓50 - 84 years of age at the time of enrolment (within year of birth, not month of birth)
  • ✓Willing to provide up to 30 mL of blood for each study visit
  • ✓Willing and eligible to undergo MRI or CT scan
  • ✓Understands the study process and is willing to take part in the study and sign the agreement to take part form

Who cannot take part

  • ✗Prior type I or type II DM diagnosis or an initial HbA1c ≥ 48 mmol/mol or 6.5% obtained prior to the 200-day...
  • ✗A history of pancreatic cancer, pancreatic neuroendocrine tumour (pNET) or Pancreatitis
  • ✗Under investigation for or confirmed pancreatic cancer
  • ✗Under investigation/surveillance for pancreatic cyst
  • ✗Any known pancreatic surgery (not including ERCP), or other major surgery requiring anaesthesia within 3 months
See the full criteria
Inclusion Criteria: * 50 - 84 years of age at the time of enrolment (within year of birth, not month of birth) * Confirmed type 2 DM diagnosis established within the last 200 days or an initial elevated HbA1c ≥ 48 mmol/mol or 6.5% obtained within the last 200 days. This includes people who have a first elevated HbA1c (≥ 48 mmol/mol or 6.5%) within the last 200 days, even if subsequent HbAc1 measurements return to the the normal range. * Willing to provide up to 30 mL of blood for each study visit * Willing and eligible to undergo MRI or CT scan * 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 or an initial HbA1c ≥ 48 mmol/mol or 6.5% obtained prior to the 200-day inclusion window, except gestational elevated HbA1c. * A history of pancreatic cancer, pancreatic neuroendocrine tumour (pNET) or Pancreatitis * Under investigation for or confirmed pancreatic cancer * Under investigation/surveillance for 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 * BMI \> 40 at the time of consent * Blood transfusion within 1 month * Solid organ transplant recipient * Currently pregnant * Needing dialysis

Where Is This Study? (31 UK sites)

Ashfields Primary Care Centre

Sandbach CW11 1EQ, United Kingdom

ACTIVE_NOT_RECRUITING

Maidstone and Tunbridge Wells NHS Trust

Maidstone ME16 9QQ, United Kingdom

Recruiting
Site contact (verified)

Forest Medical Group

Leicester LE3 3LW, United Kingdom

Recruiting
Site contact (verified)

South Leicestershire Medical Group

Kibworth Beauchamp LE8 0LG, United Kingdom

Recruiting
Site contact (verified)

Peel Croft Surgery

Burton-on-Trent DE14 3RH, United Kingdom

Recruiting
Site contact (verified)

Kingswinford Medical Practice

Kingswinford DY6 8DN, United Kingdom

Recruiting
Site contact (verified)

Park Medical Centre

Leek ST13 6QR, United Kingdom

Recruiting
Site contact (verified)

Trinity Court Surgery

Stratford-upon-Avon CV37 6HJ, United Kingdom

Recruiting
Site contact (verified)

Brockwood Medical Practice

Brockham RH3 7NJ, United Kingdom

Recruiting
Site contact (verified)

Integrated Care Partnership/ The Old Cottage Hospital

Epsom KT17 4BL, United Kingdom

Recruiting
Site contact (verified)

Warlingham Green Medical Practice

Warlingham CR6 9NW, United Kingdom

Recruiting
Site contact (verified)

Ashton Medical Group

Ashton-under-Lyne OL6 6HD, United Kingdom

ACTIVE_NOT_RECRUITING

Yardley Wood Health Centre

Birmingham B14 4DU, United Kingdom

Recruiting
Site contact (verified)

Bournemouth Research Hub

Bournemouth BH7 7DW, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Research Development & Support

clinicalresearch@bournemouth.ac.uk01202 961200

Eastham Group Practice

Bromborough CH62 6EE, United Kingdom

Recruiting
Site contact (verified)

Willesden Medical Centre

London NW10 2PT, United Kingdom

Recruiting
Site contact (verified)

South Westminster Centre

London SW1P 2PF, United Kingdom

Recruiting
Site contact (verified)

The Cuckoo Lane Practice

London W7 1DR, United Kingdom

Recruiting
Site contact (verified)

Bodey Medical Centre

Manchester M14 6WP, United Kingdom

ACTIVE_NOT_RECRUITING

Bowland Medical Practice

Manchester M23 1JX, United Kingdom

ACTIVE_NOT_RECRUITING

The Maples Medical Centre

Manchester M23 2SY, United Kingdom

ACTIVE_NOT_RECRUITING

King's Mill Hospital (Sherwood Forest) Research Van

Nottingham NG17 4JL, United Kingdom

Recruiting
Site contact (verified)

Portsmouth Research Hub

Portsmouth PO1 3HN, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Joe Shoebridge

research.office@porthosp.nhs.uk023 9228 6236

Hazelvalley Family Practice

Rossendale BB4 5SL, United Kingdom

Recruiting
Site contact (verified)

Pembroke Centre (Hillingdon)

Ruislip HA4 8NX, United Kingdom

Recruiting
Site contact (verified)

Southampton Research Hub (Shirley Research Hub)

Southampton SO15 33UA, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

Moorgreen Hospital

Southampton SO30 3JB, United Kingdom

Recruiting
Site contact (verified)

Balance Street Health Centre

Uttoxeter ST14 8JG, United Kingdom

Recruiting
Site contact (verified)

Civic Centre

Uxbridge UB8 1UW, United Kingdom

Recruiting
Site contact (verified)

Quinton Practice

Walsall WS6 6EW, United Kingdom

Recruiting
Site contact (verified)

Weymouth Research Hub

Weymouth DT4 0QE, United Kingdom

ACTIVE_NOT_RECRUITING

How to Get in Touch

SAFE-D Trial Manager

Sponsor contact

CONTACT

+442381205154 safed@soton.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-03