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Business Wire
19 hours ago
- Health
- Business Wire
ClearNote Health Avantect ® Pancreatic Cancer Test Enters Patient Enrollment Phase of Groundbreaking UK Study Targeting High-Risk Patients
SAN DIEGO--(BUSINESS WIRE)-- ClearNote Health, a company focused on improving early detection for some of the deadliest cancers, today announced initiation of patient enrollment for a landmark clinical study utilizing its Avantect ® Pancreatic Cancer Test. Sponsored by University Hospital Southampton NHS Foundation Trust, the prospective, multicenter study seeks to improve early detection of pancreatic cancer in individuals recently diagnosed with type 2 diabetes. With up to 15,000 patient participants, it will be the largest study of its kind. "We're thrilled to be part of this transformative study that could redefine how pancreatic cancer is detected and managed for patients at high risk due to a recent diabetes diagnosis," said Samuel Levy, PhD, Chief Scientific Officer at ClearNote Health. Patients with newly diagnosed type 2 diabetes are up to eight times as likely to develop pancreatic cancer as the general population. 1 In some of these cases, the diabetes symptoms may be caused by cancer affecting the function of the pancreas, which is responsible for insulin production. The new Surveillance of pAncreatic health aFter diabEtes Diagnosis (SAFE-D) study is led by Zaed Hamady, consultant pancreatic cancer surgeon at University Hospital Southampton. The single-blind, randomized controlled study will be conducted by researchers at the Southampton Clinical Trials Unit (CTU), based at the University of Southampton in the United Kingdom. The study will provide additional prospective validation data of the Avantect test and help identify early pancreatic cancer signals where present in this high-risk population. 'New onset diabetes has been linked to a six- to eight-fold increase in pancreatic cancer risk,' said Mr. Hamady. 'This patient group provides a valuable opportunity to better understand the exact relationship between these diseases and further validate ClearNote Health's blood-based Avantect Pancreatic Cancer Test, which has the potential to benefit thousands of people in the UK.' Dr. Victoria Goss, Head of Early Diagnosis and Translational Research at the Southampton Clinical Trials Unit, emphasized the study's community-focused approach. 'We recognize that access to healthcare and clinical trials is often uneven,' she said. 'By conducting the SAFE-D study through local research hubs and community hospitals, we aim to make early cancer detection research more inclusive and equitable.' 'We are proud to sponsor this cutting-edge study, which holds tremendous potential to improve outcomes for patients facing this devastating disease,' said Dr. Mikayala King, Research and Development Governance, Quality Assurance and Sponsorship Manager at University Hospital Southampton NHS Foundation Trust. 'Our collaboration with ClearNote and the CTU builds on a strong foundation of excellence in cancer research.' The Avantect Pancreatic Cancer Test is an innovative blood test designed for individuals at elevated risk of pancreatic cancer — particularly those over age 50 who are newly diagnosed with type 2 diabetes, individuals with a family history of the disease, or those with a genetic predisposition. The test analyzes the epigenomic biomarker 5-hydroxymethylcytosine (5hmC) in cell-free DNA, combined with other genomic data, to detect pancreatic cancer at its earliest and most treatable stages. Unlike conventional methods, ClearNote's approach provides a deeper understanding of the underpinnings of cancer development to inform the next steps in a patient care pathway. 'Early detection is the key to saving lives from the deadliest cancers,' said Samuel Levy, PhD, Chief Scientific Officer at ClearNote Health. 'We intend to demonstrate that the Avantect test can identify pancreatic cancer in stages I and II, and we're thrilled to be part of this transformative study that could redefine how pancreatic cancer is detected and managed for patients at high risk due to a recent diabetes diagnosis.' For more information on the SAFE-D study, please visit For more information on the Avantect Pancreatic Cancer Test, please visit 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 or follow the company on LinkedIn. References 1. 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/
Yahoo
30-04-2025
- Health
- Yahoo
GSK's Zejula reduces risk of progression and death in mesothelioma study
GSK's Zejula (niraparib) has reduced the risk of death or progression by 27% in patients with mesothelioma in an investigator-led Phase II trial. The NERO study (NCT05455424) investigated the efficacy of Zejula in 88 mesothelioma patients who relapsed after previously receiving platinum-based systemic therapy. The study is sponsored by the University Hospital Southampton NHS Foundation Trust and funded by Asthma + Lung UK, with support from Mesothelioma UK and the Mavis Nye Foundation. Mesothelioma is a highly aggressive cancer that forms in the protective lining surrounding certain internal organs, most commonly the lungs, and is usually linked to asbestos exposure. Treatments are limited, and the standard of care (SOC) includes surgery, chemotherapy, radiation therapy, and immunotherapy. Those treated with Zejula benefited from an average of 1.5 months progression-free survival (PFS) compared to SOC – marking a 27% reduction in the risk of the cancer progressing or death. Professor Gareth Griffiths, director of the Southampton Clinical Trials Unit and co-lead of the trial, said: 'Although this increase may seem small, for this group of patients who have very few treatment options and a generally poor prognosis, this is a significant step forward. "We have shown for the first time that this kind of drug can improve progression-free survival for mesothelioma patients compared with their usual treatment in the NHS. This gives enormous hope to those patients and their families and means we can now carry out further research to find out more about how these treatments could be tailored and enhanced to stimulate an even better response in more people.' The data was presented at the American Association of Cancer Research (AACR) Annual Meeting 2025 in Chicago, US, on 29 April. The University Hospital Southampton NHS Foundation Trust is now keen to initiate a new study, SELECTmeso, which will be a Phase II platform trial in patients with confirmed histological diagnosis of mesothelioma with evidence of MTAP loss on immunohistochemistry, and evidence of disease progression following prior standard systemic therapy on CT scan. Griffiths added: 'This trial will see patients tested for certain biomarkers, or genetic signals, in their tumours and then given the drug that is most likely to work for them. We really hope this step into more personalised medicine could further help these patients who desperately need better treatment options.' Zejula is an oral poly-ADP ribose polymerase (PARP) inhibitor that was approved on 27 March 2017 by the US Food and Drug Administration (FDA) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Other PARP inhibitors being investigated in patients with mesothelioma include AstraZeneca's Lynparza (olaparib), which is currently in a Phase II trial (NCT04515836); and Pfizer's Talzenna (talazoparib), which is also in a Phase II study (NCT04462809). AstraZeneca is also studying volrustomig, a bispecific antibody immunotherapy that targets and blocks PD-1 and CTLA-4. The drug is currently being evaluated in a Phase III trial for malignant pleural mesothelioma (NCT06097728). In September 2024, the FDA approved MSD's Keytruda in combination with chemotherapy as a treatment for unresectable advanced or metastatic malignant pleural mesothelioma, based on data from the KEYNOTE-483 (NCT02784171) study. "GSK's Zejula reduces risk of progression and death in mesothelioma study" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
