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2025-03-03
2031-02-28
2032-02-29
15000
NCT06803771
University Hospital Southampton NHS Foundation Trust
University Hospital Southampton NHS Foundation Trust
INTERVENTIONAL
Surveillance of Pancreatic Health After Diabetes Diagnosis
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-01-27 | N/A | 2025-01-27 |
2025-01-27 | N/A | 2025-01-31 |
2025-01-31 | N/A | 2025-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: 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 furth | DEVICE: Avantect Pancreatic Cancer Test
|
| PLACEBO_COMPARATOR: 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 tes | DEVICE: Avantect Pancreatic Cancer Test
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Sensitivity of the Avantect test | 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. | 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. |
| Specificity of the Avantect test | 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. | 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. |
| Resectability rate of pancreatic cancer | The proportion of pancreatic cancers deemed resectable by the study MDT divided by the number of pancreatic cancers and will be compared between arms. | 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. |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Stage shift | 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. | 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. |
| 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 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. | 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. |
| Negative Predictive Value (NPV) of Avantect test in ruling out pancreatic cancer (PC) | 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. | 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. |
| Resection rate of pancreatic cancer | 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. | 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. |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: SAFE-D Trial Manager Phone Number: +442381205154 Email: safed@soton.ac.uk |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
50 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
