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 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.

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 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.

Enrollment

5,000 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)
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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

5,000 participants in 1 patient group

Interventional

Experimental group

Description:

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.

Treatment:

Device: Avantect Pancreatic Cancer Test

Trial contacts and locations

Central trial contact

SAFE-D Trial Manager

Data sourced from clinicaltrials.gov

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