Surveillance of Pancreatic Health After Diabetes Diagnosis
The registry record from ClinicalTrials.gov (public domain): summary, interventions, outcomes and eligibility. Questions are answered only with quotes from this document. Source: ClinicalTrials.gov, retrieved 2026-11-05.
Ongoing
Record metadata
- Phase
- NA
- Status
- Recruiting
- Start
- 2025-05-21
- End
- 2032-07
- Enrollment
- 5,000
- Sites
- 31
- Sponsor class
- OTHER
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Source text
Brief summary · public domain (ClinicalTrials.gov) · T1
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.
Detailed description · public domain (ClinicalTrials.gov) · T1
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.
Intervention · public domain (ClinicalTrials.gov) · T1
Device: Avantect Pancreatic Cancer Test. Avantect test
Arm · public domain (ClinicalTrials.gov) · T1
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.
Primary outcome · public domain (ClinicalTrials.gov) · T1
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..
Primary outcome · public domain (ClinicalTrials.gov) · T1
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..
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Stage shift. Time frame: The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants..
Secondary outcome · public domain (ClinicalTrials.gov) · T1
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..
Secondary outcome · public domain (ClinicalTrials.gov) · T1
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..
Secondary outcome · public domain (ClinicalTrials.gov) · T1
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..
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Resectability. Time frame: The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants..
Eligibility · public domain (ClinicalTrials.gov) · T1
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
Enrollment · public domain (ClinicalTrials.gov) · T1
Enrollment: 5000 participants (estimated).