Institute of Oncology and Molecular Genetics Set to Work in the PREDI-LYNCH Project
On 15 May, the European Commission approved the project 'Validated non-invasive liquid biopsy tests for cancer prediction in LYNCH Syndrome, PREDI-LYNCH'. The project was officially launched on 1 May, and it is funded by the European Commission's Horizon Europe Mission on Cancer with 13.6 million Euro (project No. 101213916). PREDI-LYNCH will run for six years (2025–2031), and the consortium consists of 28 partners from 16 European countries, RSU Institute of Oncology and Molecular Genetics being one of them. The initiative is led by researcher Mev Dominguez-Valentin at the Insitute for Cancer Research, Oslo University Hospital.
Innovative project focusing on early detection of hereditary cancer
PREDI-LYNCH sets out to make a difference for people with Lynch syndrome (LS) by developing and implementing novel, non-invasive early detection methods for colorectal, endometrial and urothelial cancers in patients with LS. The research team addresses an unmet medical need in providing an innovative approach to biomarker discovery for early-stage cancers in LS patients. The consortium gathers leading European researchers, clinicians, biotech companies and patient advocates. Together they aim for setting new standards in early cancer detection for rapid upscaling, for clinical adoption across EU and globally. The project has potential to change clinical practice.
The project will use an innovative clinical trial design for evaluating several promising non-invasive liquid biopsy-based technologies in the three most common LS cancer types to detect cancer at an early stage. Artificial intelligence (AI) will also be utilized to identify traces of cancer and to ensure that the methods are applicable in different healthcare systems. In addition, socio-economic and ethical consequences will be assessed to ensure that the solutions are in line with patients and societal needs and in being implementable in different healthcare systems. The long-term ambition is to offer a multi-omics solution for affordable, accessible and effective testing to ensure early detection in LS patients.
Lynch syndrome and hereditary cancer
LS is an autosomal dominant cancer syndrome caused by pathogenic germline variants in one of the DNA mismatch repair (MMR) genes. It is the most common monogenic hereditary cancer predisposition syndrome worldwide. Carriers of pathogenic MMR variants have a high lifetime risk of developing colorectal (CRC), gynaecological, and urothelial tract cancers as well as, and less frequently other cancers at other sites, including gastric, duodenal, small bowel, pancreatic, biliary tract, prostate, kidney, brain, and skin cancers.
LS affects 1 in 440 people of European ancestry. However, many are unaware of their risk, and only 5 % of the 2 million estimated LS carriers in Europe are under cancer surveillance. Tumour-based MMR screening is now routine, which has greatly increased the number of people diagnosed with LS, but this is meaningless without effective means to reduce their cancer risk. CRC, endometrial, and urothelial cancers are most common in LS. Despite CRC surveillance and aspirin use, up to 60 % of LS carriers still develop CRC, and 80 % get some form of cancer. Gynaecological surveillance in LS, i.e., transvaginal ultrasound and endometrial biopsy, is invasive and painful, while evidence of benefits is lacking. The studies are of low quality and have contradictory outcomes. Therefore, women are recommended to undergo a hysterectomy in their early forties. For urothelial cancers, there is no established means of surveillance, meaning that these cancers are often detected at an advanced stage. Uretero-cystoscopy, commonly used for urothelial cancer diagnosis, is invasive and expensive, whereas urinalysis or urine cytology is ineffective. We therefore urgently need to improve cancer surveillance in LS to detect cancers at an early stage, utilising effective and minimally invasive strategies, so as to improve patient outcomes and compliance. This is what PREDI-LYNCH will focus on.
Main partners about the project
I see this as a great opportunity for the benefit of the Lynch syndrome patients. The project will develop a unique biobank for Lynch syndrome patients that will serve as a unique resource for research and understanding on Lynch syndrome for many years to come. We will also, building on our long-standing research, develop effective and scalable early screening tests, based on our contributions to the existing European clinical guidelines towards the goal of precision medicine tailored to each patient.
PhD Mev Dominguez-Valentin, leader of the PREDI-LYNCH project
We are excited to collaborate and contribute our expertise in metabolism-based biomarkers to aid in the early detection of cancers associated with LYNCH Syndrome. Strong partnerships between academia and industry are essential for driving innovation and implementing diagnostic solutions, particularly in the field of rare diseases. By working together, we can overcome key challenges and accelerate the development of cutting-edge technologies that improve patient outcomes.
Dr Volker Liebenberg, Chief Medical Officer at Elypta
