UK NHS project will support the clinical validity and utility of early pancreatic cancer detection and surveillance testing in up to 15,000 patients with newly diagnosed type 2 diabetes

ClearNote Health, a company focused on improving early detection for some of the deadliest cancers, today announced a new collaboration with research teams in Southampton in the United Kingdom. Researchers at the Southampton Clinical Trials Unit, based at the University of Southampton, will use the ClearNote Health Avantect® Pancreatic Cancer Test in a landmark study, sponsored by University Hospital Southampton NHS Foundation Trust, that builds on the well-established relationship between pancreatic cancer and type 2 diabetes. The prospective, multicenter study will be the largest of its kind, including up to 15,000 patient participants recently diagnosed with type 2 diabetes.

While early detection has vastly improved survival rates for many types of cancer, pancreatic cancer is often diagnosed at an advanced metastatic stage when patients have a five-year survival rate as low as 3%.¹ The Avantect test is a blood-based assay designed to use key epigenomic and genomic signals to detect the earliest indicators of pancreatic cancer. It is targeted for use in populations at high risk of developing this type of cancer.

One of those populations includes patients with newly diagnosed type 2 diabetes, who are nearly eight times as likely to develop pancreatic cancer as the general population.² While the exact relationship between these diseases is not yet fully understood, it is thought that in a small percentage of people newly diagnosed with type 2 diabetes, the symptoms may actually be caused by cancer affecting the function of the pancreas, which is responsible for insulin production. A large proportion of patients with pancreatic cancer have either newly diagnosed type 2 diabetes or longstanding diabetes.³

The new Surveillance of pAncreatic health aFter diabEtes Diagnosis (SAFE-D) study aims to determine whether pancreatic cancer signals are present in patients who were recently diagnosed with type 2 diabetes. Led by Zaed Hamady, a consultant surgeon specializing in pancreatic cancer at the University Hospital Southampton, the single-blinded, interventional, randomized, controlled study will provide valuable information about the integration of early pancreatic cancer detection and ongoing surveillance in new-onset type 2 diabetes care. It will also expand the clinical validity and utility of the Avantect test in a high-risk patient population. The study is scheduled to begin with a pilot phase in the first quarter of 2025.

“Unfortunately, the majority of pancreatic cancer cases are detected very late, when treatment options are limited,” said Mr. Hamady. “We hope that this large study will confirm the Avantect test’s ability to detect the cancer at an early stage, so treatment can begin quickly, which should lead to much better outcomes and possible curative treatment for patients.”

“Our trials unit has expertise in running large studies to evaluate new and innovative early detection tests for diseases where we know late diagnosis means poorer outcomes for patients,” said Dr. Victoria Goss, Head of Early Diagnosis and Translational Research at the Southampton Clinical Trials Unit. “We are excited to be collaborating with ClearNote Health and Mr. Hamady’s team to carry out the SAFE-D study and hope it can lead to better diagnosis and treatment for pancreatic cancer patients in the future.”

“We are excited to be sponsoring this cutting-edge study with potential benefit to patients with this devastating disease,” said Dr. Mikayala King, Research and Development Governance, Quality Assurance and Sponsorship Manager at University Hospital Southampton NHS Foundation Trust. “We are happy to be working with ClearNote and to be building on our long-established relationship with the CTU to manage and deliver the project.”

The Avantect Pancreatic Cancer Test is a simple blood test for patients at high risk of pancreatic cancer, including those newly diagnosed with type 2 diabetes who are at least 50 years old, as well as those with a family history and/or a genetic predisposition. It was designed to detect pancreatic cancer in its earliest stages by profiling the epigenomic biomarker 5-hydroxymethylcytosine (5hmC) in cell-free DNA and combining that data with other genomic information. Unlike conventional methods, ClearNote’s 5hmC-based approach provides a deeper understanding of the underpinnings of cancer development with an unprecedented level of clarity to inform the next steps in a patient care pathway.

“Early cancer detection can be the difference between life and death, but clinicians are too often constrained by the limitations of existing diagnostic technologies,” said Samuel Levy, PhD, Chief Scientific Officer at ClearNote Health. “Today, pancreatic cancer is a devastating diagnosis, but early detection could make a world of difference for these patients. ClearNote Health is focused on transforming the patient care paradigm with a new epigenomics-based approach that allows clinicians to detect and monitor cancers at a more treatable stage so patients can live longer, healthier lives.”

For more information on the Avantect Pancreatic Cancer Test, please visit www.avantect.com.

About ClearNote Health

ClearNote Health is a privately held company dedicated to improving early detection and monitoring for some of the deadliest forms of cancer. Developed by scientists in the Stephen Quake laboratory at Stanford University, the company’s patented core Virtuoso™ epigenomics platform builds on the latest advances in artificial intelligence and bioinformatics to measure active biological differences between cancer and healthy cells in a blood sample. The company’s highly sensitive, noninvasive Avantect® Pancreatic and Ovarian diagnostic tests are designed to identify cancers in high-risk patient populations far earlier than conventional approaches, when patients are most likely to benefit from treatment. ClearNote Health’s headquarters and CLIA-certified, CAP-accredited laboratory are located in San Diego. For more information, visit www.clearnotehealth.com or follow the company on X or LinkedIn.

References

1. Rawla P, Sunkara T, Gaduputi V. Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 2019 Feb;10(1):10-27. doi: 10.14740/wjon1166.

2. Chari ST, Leibson CL, Rabe KG, Ransom J, de Andrade M, Petersen GM. Probability of pancreatic cancer following diabetes: a population-based study. Gastroenterology. 2005 Aug;129(2):504-11. doi: 10.1016/j.gastro.2005.05.007.

3. De Souza A, Irfan K, Masud F, Saif MW. Diabetes Type 2 and Pancreatic Cancer: A History Unfolding. JOP. 2016 Mar;17(2):144-148.

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