Clinical trial NCT06803771: Surveillance of Pancreatic Health After Diabetes Diagnosis
Official title: A Randomised Trial to Evaluate the CfDNA Pancreatic Cancer Test (Avantect) in the Early Detection of Pancreatic Cancer in Patients with Newly Diagnosed Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Pancreatic Cancer, Adult
Keywords: Type 2 diabetes
pancreatic cancer
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: ClearNote Health
First posted: 2025-01-31
Enrollment: 15000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be blindly randomised in 1:1 ratio to either the intervention arm or the control arm.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of the Avantect test
timeFrame: 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.
measure: Specificity of the Avantect test
timeFrame: 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.
measure: Resectability rate of pancreatic cancer
timeFrame: 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 outcomes:
measure: Stage shift
timeFrame: 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.
measure: Positive Predictive Value (PPV) of Avantect test in detecting pancreatic cancer (PC)
timeFrame: 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.
measure: Negative Predictive Value (NPV) of Avantect test in ruling out pancreatic cancer (PC)
timeFrame: 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.
measure: Resection rate of pancreatic cancer
timeFrame: 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.
Other outcomes:
measure: Time-to-event outcomes
timeFrame: 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.
measure: Overall survival
timeFrame: 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.
measure: Effect of the Avantect test on state anxiety over time
timeFrame: 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.
measure: High-grade neoplasia
timeFrame: 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.
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