Surveillance of Pancreatic Health After Diabetes Diagnosis (SAFE-D)

University Hospital Southampton NHS Foundation Trust

Status: Enrolling

Conditions: Pancreatic Cancer, Adult; Diabetes Mellitus

Treatments: Device: Avantect Pancreatic Cancer Test

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06803771

RHMGSU0292

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15,000 estimated patients

Sex: All

Ages: 50 to 84 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15,000 participants in 2 patient groups, including a placebo group

Intervention Arm

Experimental group

Description:

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 further MRI or CT investigations by the local clinical team.

Treatment:

Device: Avantect Pancreatic Cancer Test

Control Arm (Standard of Care [SoC] arm)

Placebo Comparator group

Description:

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 testing and/ or future research.

Treatment:

Device: Avantect Pancreatic Cancer Test