GUIDE.MRD (GUIding multi-moDal thErapies against MRD by liquid biopsies) is a European project within the framework of the Innovative Health Initiative (IHI) of the European Commission. It is a public-private partnership of leading academics, industry, patient organizations and other experts. It is a 5-year project aiming to improve the standard of care in oncology for three types of cancer: Lung cancer, pancreatic cancer, and colorectal cancer. The project is exploring blood tests, referred to as “liquid biopsies”, that can help guide treatment choices for cancer patients after surgery and improve outcomes for patients.
Patients with early-stage cancer usually undergo surgery (sometimes combined with chemotherapy or radiochemotherapy) to completely remove and destroy the tumour with the aim of complete cure. After surgery and (radio)chemotherapy, it is often hard to tell if all the cancer has been removed or if it may have spread to other parts of the body or escaped the treatment undetectable by medical imaging. Since a very small number of cancer cells may be undetectable using imaging methods such as CT scans, a blood sample (or liquid biopsy) can be analysed to look for minute amounts of circulating Tumour DNA (ctDNA), small fragments of cancer cells. When a few cancer cells are remaining in the body which are not detectable by medical imaging, this is referred to as Minimal Residual Disease (MRD). In these situations, the level of MRD shown through ctDNA testing may help to determine which patients may need additional treatment after surgery, also called adjuvant therapy. Adjuvant therapy can be a single option, such as chemotherapy, or can be a combination of multi-modal treatments (treatments that work in different ways, such as chemotherapy in combination with immunotherapy or radiotherapy by irradiation of the affected tumor localization).
GUIDE.MRD will address two key unmet needs for patients:
There are many ctDNA tests available that can be used to examine MRD. However, they may vary in the amount of ctDNA they can detect in the blood, there are no international standards and indicators of quality in testing. GUIDE.MRD aims to determine the accuracy of these tests to give doctors, patients and regulators more confidence in the results. This will help to understand the best tests to use and how ctDNA testing can become part of routine care after surgery (and adjuvant treatment if applicable).
Moreover, treatment decision making for patients after surgery can be difficult for doctors and their patients. Using ctDNA testing may provide information to decide if patients need treatment, which treatment or multi-modal combination will work best, and monitor how well treatments work. This may lead to better outcomes and reduced burden on patients and their families. The best treatments can be used, patients may experience fewer treatment side effects, or patients might also avoid unnecessary treatments.
The GUIDE.MRD project will examine ctDNA liquid biopsies with three main objectives:
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This project is supported by the Innovative Health Initiative Joint Undertaking (JU) under grant agreement No 101112066.
The JU receives support from the European Union’s Horizon Europe research and innovation programme and EFPIA (including Vaccines Europe), MedTech Europe and LGC Clinical Diagnostics INC.
Funded by the European Union, the private members, and those contributing partners of the IHI JU. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the aforementioned parties. Neither of the aforementioned parties can be held responsible for them.