Surveillance of Pancreatic Health After Diabetes Diagnosis

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus; Pancreatic Cancer, Adult

• Registration Number: NCT06803771
• Lead Sponsor: University Hospital Southampton NHS Foundation Trust

Brief 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 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.

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 Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-01-27
• Last Update Submitted: 2025-01-27
• Study First Posted: 2025-01-31
• Last Update Posted: 2025-01-31
• Study Start: 2025-03-03
• Primary Completion: 2031-02-28
• Study Completion: 2032-02-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sensitivity of the Avantect test	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.
Specificity of the Avantect test	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.
Resectability rate of pancreatic cancer	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.

Secondary Outcome Measures

Name	Time	Method
Stage shift	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.
Positive Predictive Value (PPV) of Avantect test in detecting pancreatic cancer (PC)	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.
Negative Predictive Value (NPV) of Avantect test in ruling out pancreatic cancer (PC)	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.
Resection rate of pancreatic cancer	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.