An interventional study of Avantect Pancreatic Cancer Test in Diabetes Mellitus and Pancreatic Cancer, Adult, sponsored by University Hospital Southampton NHS Foundation Trust. Recruiting at 31 sites in United Kingdom. Open to participants aged 50 Years to 84 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by University Hospital Southampton NHS Foundation Trust · Not applicable, Interventional, and Diagnostic
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:
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.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University Hospital Southampton NHS Foundation Trust is the lead sponsor of 150 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Sep 25, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Avantect Pancreatic Cancer Test
Avantect test
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.
Time frame: 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.
Time frame: The final analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.
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.
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)
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.
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)
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.
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
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.
Time frame: 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.
Time frame: The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.
Time-to-event outcomes
To estimate the time from new onset diabetes diagnosis to pancreatic cancer diagnosis.
Time frame: The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.
Overall survival
To estimate the overall survival of study participants.
Time frame: The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.
Effect of the Avantect test on state anxiety over time
To assess the effect of the Avantect test on state anxiety over time.
Time frame: The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.
High-grade neoplasia
To investigate the performance characteristics for high-grade neoplasia.
Time frame: The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.
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Plan to share: Undecided
Started May 2025 (actual). Primary completion is estimated for Jul 2029, 50 months after the start.
Of 1,583 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 50 months is above that.
Counting every sponsor, half of 1,743 studies reached it within 21 months; a quarter within 9 and three quarters within 42.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 25, 2026: primary completion Feb 2028 → Jul 2029 and completion Feb 2029 → Jul 2032.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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