Diabetes MellitusSAFE-DNCT06803771

Surveillance of Pancreatic Health After Diabetes Diagnosis

A study testing Avantect Pancreatic Cancer Test in people with Diabetes Mellitus and Pancreatic Cancer, Adult, run by University Hospital Southampton NHS Foundation Trust at 31 sites in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial 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 or with elevated sugar levels within the last 200 days. Read more about this study

Who is it for?: Ages 50 to 84 years
Conditions the study is for: Diabetes Mellitus, Pancreatic Cancer, Adult
What is being tested?: Avantect Pancreatic Cancer Test
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5,000 participants
Where: 31 sitesUnited Kingdom
Study dates: 21 May 2025to Jul 2032
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 84 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

BMI > 40 at the time of consent
Blood transfusion within 1 month
Solid organ transplant recipient
Currently pregnant
Needing dialysis

Trial locations and contacts

31 sites in 1 country. Contact the study team or a site near you to ask about taking part.

SAFE-D Trial Manager contact

+442381205154

safed@soton.ac.uk

City, postcode or hospital

Sites recruiting now only

31 sites in 1 country

United Kingdom31 sites, 22 recruiting

Ashton Medical Group
Ashton-under-Lyne, OL6 6HD
Active, not recruiting
Yardley Wood Health Centre
Birmingham, B14 4DU
Anson-Wisniewska, 02380215154, safed@soton.ac.uk
Recruiting
Bournemouth Research Hub
Bournemouth, BH7 7DW
Active, not recruiting
Brockwood Medical Practice
Brockham, Surrey, RH3 7NJ
Anson-Wisniewska, 02380215154, safed@soton.ac.uk
Recruiting
Eastham Group Practice
Bromborough, CH62 6EE
Anson-Wisniewska, 02380215154, safed@soton.ac.uk
Recruiting
Peel Croft Surgery
Burton-on-Trent, Staffordshire, DE14 3RH
Anson-Wisniewska, 02380215154, safed@soton.ac.uk
Recruiting
Integrated Care Partnership/ The Old Cottage Hospital
Epsom, Surrey, KT17 4BL
Anson-Wisniewska, 02380215154, safed@soton.ac.uk
Recruiting
South Leicestershire Medical Group
Kibworth Beauchamp, Leicestershire, LE8 0LG
Anson-Wisniewska, 02380215154, safed@soton.ac.uk
Recruiting
Kingswinford Medical Practice
Kingswinford, Staffordshire, DY6 8DN
Anson-Wisniewska, 02380215154, safed@soton.ac.uk
Recruiting
Park Medical Centre
Leek, Staffordshire, ST13 6QR
Anson-Wisniewska, 02380215154, safed@soton.ac.uk
Recruiting
Forest Medical Group
Leicester, Leicester Forest East, LE3 3LW
Anson-Wisniewska, 02380215154, safed@soton.ac.uk
Recruiting
Willesden Medical Centre
London, NW10 2PT
Anson-Wisniewska, 02380215154, safed@soton.ac.uk
Recruiting
South Westminster Centre
London, SW1P 2PF
Anson-Wisniewska, 02380215154, safed@soton.ac.uk
Recruiting
The Cuckoo Lane Practice
London, W7 1DR
Anson-Wisniewska, 02380215154, safed@soton.ac.uk
Recruiting
Maidstone and Tunbridge Wells NHS Trust
Maidstone, Kent, ME16 9QQ
Anson-Wisniewska, 02380215154, safed@soton.ac.uk
Recruiting
Bodey Medical Centre
Manchester, M14 6WP
Active, not recruiting
Bowland Medical Practice
Manchester, M23 1JX
Active, not recruiting
The Maples Medical Centre
Manchester, M23 2SY
Active, not recruiting
King's Mill Hospital (Sherwood Forest) Research Van
Nottingham, NG17 4JL
Anson-Wisniewska, 02380215154, safed@soton.ac.uk
Recruiting
Portsmouth Research Hub
Portsmouth, PO1 3HN
Active, not recruiting
Hazelvalley Family Practice
Rossendale, BB4 5SL
Anson-Wisniewska, 02380215154, safed@soton.ac.uk
Recruiting
Pembroke Centre (Hillingdon)
Ruislip, HA4 8NX
Anson-Wisniewska, 02380215154, safed@soton.ac.uk
Recruiting
Ashfields Primary Care Centre
Sandbach, Cheshire, CW11 1EQ
Active, not recruiting
Southampton Research Hub (Shirley Research Hub)
Southampton, SO15 33UA
Active, not recruiting
Moorgreen Hospital
Southampton, SO30 3JB
Anson-Wisniewska, 02380215154, safed@soton.ac.uk
Recruiting
Trinity Court Surgery
Stratford-upon-Avon, Staffordshire, CV37 6HJ
Anson-Wisniewska, 02380215154, safed@soton.ac.uk
Recruiting
Balance Street Health Centre
Uttoxeter, ST14 8JG
Anson-Wisniewska, 02380215154, safed@soton.ac.uk
Recruiting
Civic Centre
Uxbridge, UB8 1UW
Anson-Wisniewska, 02380215154, safed@soton.ac.uk
Recruiting
Quinton Practice
Walsall, WS6 6EW
Anson-Wisniewska, 02380215154, safed@soton.ac.uk
Recruiting
Warlingham Green Medical Practice
Warlingham, Surrey, CR6 9NW
Anson-Wisniewska, 02380215154, safed@soton.ac.uk
Recruiting
Weymouth Research Hub
Weymouth, DT4 0QE
Active, not recruiting

Other trials in United Kingdom

About this study

Official title: An Interventional Study to Evaluate the cfDNA Pancreatic Cancer Test (Avantect) in the Early Detection of Pancreatic Cancer in Participants With Newly Diagnosed Diabetes Mellitus or Newly Elevated HbA1c

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.

Read the 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 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.

Conditions: Diabetes Mellitus, Pancreatic Cancer, Adult
Being tested: Avantect Pancreatic Cancer Test
Keywords: Type 2 diabetes, pancreatic cancer
Medical subject headings: Diabetes Mellitus, Pancreatic cancer, adult, Diabetes Mellitus, Type 2, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Avantect Pancreatic Cancer TestDevice
Avantect test

Study groups in NCT06803771
Study group	Role	What they receive
Interventional	Experimental	Participants 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. Receives: Device: Avantect Pancreatic Cancer Test

What is being measured

The primary outcome is the main question the study is designed to answer.

Sensitivity of the Avantect test
The proportion of individuals with one or more Avantect "detected" test result who have pancreatic cancer diagnosed via imaging in relation to all individuals in the study who had pancreatic cancer diagnosed.
Measured: The final analysis will be carried out after 3-year follow up data has been collected for all 5,000 participants.
Specificity of the Avantect test
The proportion of individuals 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 study who did not have a pancreatic cancer diagnosis.
Measured: The final analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.

Secondary outcomes (5)

Stage shift
The proportion of pancreatic cancers cases diagnosed at stage I/II out of all participants diagnosed with pancreatic cancer between SAFE-D participants and point-estimate of the proportion from comparative data.
Stage shift will be considered successful if the lower-bound of the 95% one-sided proportion in SAFE-D participants is higher than the proportion from comparative data.
Measured: The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.
Positive Predictive Value (PPV) of Avantect test in detecting pancreatic cancer (PC)
Percentage of participants with an Avantect "detected" result who have pancreatic cancer diagnosed. The analysis will be conducted with a sample size of 5,000, pancreatic cancer prevalence of 0.8%, and 5% lost from the per protocol population. There will be an expected 261 individuals with an Avantect "detected" result. 9.6% (25/261) 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.
Measured: The final analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.
Negative Predictive Value (NPV) of Avantect test in ruling out pancreatic cancer (PC)
With a sample size of 5,000, PC prevalence of 0.8%, and 5% lost from the per protocol population, there will be an expected 4,489 individuals without an Avantect "detected" result. 99.6% (4,476/4,489) 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.
Measured: The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.
Resection rate of pancreatic cancer
Percentage of participants with pancreatic cancer who underwent resection. The analysis will be conducted by comparing the proportion of pancreati cancer cases that underwent resection as a treatment modality between SAFE-D participants and the point-estimate of the proportion from comparative data. Resection rate will be considered successful if the lower-bound of the 95% one-sided proportion in SAFE-D participants is higher than the proportion from comparative data.
Measured: The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.
Resectability
Percentage of pancreatic cancers deemed resectable by the study MDST.
Measured: The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 May 2025Jul 2032

First posted31 Jan 2025
Study start21 May 2025
Primary completion29 Jul 2029 (estimated)
Study completionJul 2032 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Model description: Participants will have their blood samples tested on the Avantect test.
Masking: None (open label)
Enrolment: 5,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06803771
Sponsor's protocol ID: RHMGSU0292
Acronym: SAFE-D
Status last verified: Mar 2026
First submitted: 27 Jan 2025
Last updated: 28 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Interested in taking part?

SAFE-D Trial Manager

+442381205154

safed@soton.ac.uk

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Interventional Study to Evaluate the cfDNA Pancreatic Cancer Test (Avantect) in the Early Detection of Pancreatic Cancer in Participants With Newly Diagnosed Diabetes Mellitus or Newly Elevated HbA1c
ClinicalTrials.gov ID: NCT06803771
Acronym / sponsor ID: SAFE-D / RHMGSU0292
Conditions: Diabetes Mellitus, Pancreatic Cancer, Adult
Keywords: Type 2 diabetes, pancreatic cancer
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 5,000 participants (estimated)
Lead sponsor: University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
Collaborators: ClearNote Health
Study start: 21 May 2025 (actual)
Primary completion: 29 Jul 2029 (estimated)
Study completion: Jul 2032 (estimated)
First posted: 31 Jan 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Participants will have their blood samples tested on the Avantect test.

Arm	Type	Receives
Interventional	Experimental	Device: Avantect Pancreatic Cancer TestParticipants 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.

Who may qualify

Ages: 50 to 84 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Avantect Pancreatic Cancer TestAvantect test	Device	Interventional

Primary outcome

Sensitivity of the Avantect test
Time frame: The final analysis will be carried out after 3-year follow up data has been collected for all 5,000 participants.
The proportion of individuals with one or more Avantect "detected" test result who have pancreatic cancer diagnosed via imaging in relation to all individuals in the study who had pancreatic cancer diagnosed.
Specificity of the Avantect test
Time frame: The final analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.
The proportion of individuals 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 study who did not have a pancreatic cancer diagnosis.

5 secondary outcomes

Stage shift
Time frame: The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.
Positive Predictive Value (PPV) of Avantect test in detecting pancreatic cancer (PC)
Time frame: The final analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.
Negative Predictive Value (NPV) of Avantect test in ruling out pancreatic cancer (PC)
Time frame: The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.
Resection rate of pancreatic cancer
Time frame: The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.
Resectability
Time frame: The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

Related trials for Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

SAFE-D Trial Manager contact

+442381205154

safed@soton.ac.uk

31 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact SAFE-D Trial Manager (+442381205154, safed@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity of the Avantect test (time frame: The final analysis will be carried out after 3-year follow up data has been collected for all 5,000 participants.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06803771.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.