SAFE-D: Surveillance of pAncreatic health aFter diabEtes Diagnosis
Research type
Research Study
Full title
SAFE-D: Surveillance of pAncreatic health aFter diabEtes Diagnosis 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.
IRAS ID
326332
Contact name
Zaed Hamady
Contact email
Sponsor organisation
University Hospital Southampton NHS FT
Duration of Study in the UK
6 years, 11 months, 29 days
Research summary
Pancreatic cancer 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 collect blood samples, clinical and anxiety questionnaire data from up to 15,000 individuals aged 50-84 years old diagnosed with type II diabetes within the last 6 months. The study will recruit participants from GP practices over 3 years with each participant attending three visits over 12 months.
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.
Every participant sample and related clinical data will provide us with a wealth of information which will help us understand and treat pancreatic cancer patients better.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
25/EM/0016
Date of REC Opinion
26 Feb 2025
REC opinion
Further Information Favourable Opinion