Revolutionizing medical research with LogiqSuite

ORTEC will contribute with LogiqSuite, a GDPR-compliant data management system for medical research. LogiqSuite allows collaboration in personalized medicine with data entry, automated data import, real-time analytics, machine learning for developing prediction models, coupling to clinical-decision support tools, and continual learning from medical data. Data from 60 hospitals involved in these two randomized clinical trials will be entered into LogiqSuite. The project will also establish two registries for blood cell cancers with patient data from 8 countries, intended for long-term continuation.

Advancing leukemia treatment and patient outcomes through research collaboration

The consortium leverages existing expert networks and partnerships with patient participation for the study. "If we confirm MRD as a biomarker, it will be used to guide the treatment of AML and CLL across Europe in the future," says Professor Heuser, Corsortium Leader. This development could make more intensive therapies such as stem cell transplants unnecessary for some patients and shorten treatment times for others, improving patients’ quality of life and reducing treatment costs. The European Union is funding the project with a total of eight million euros over five years, with 570,000 euros allocated to ORTEC.

Equal chances of cure with fewer side effects

In flow cytometry, several hundred thousand cells can be examined simultaneously in a high-throughput process within a short period, enabling the detection of individual leukemia cells amidst healthy blood cells. "It's like searching for a needle in a haystack, or for a single red ball in a pool of white balls," explains Professor Heuser. The treatment goal is to no longer find a red ball, meaning that no more leukemia cells are present in the body. Building on this, the researchers are investigating whether fewer medications or a shorter treatment for MRD-negative patients offer the same chances of cure – with fewer side effects." In some countries, MRD measurement is already used to individually assess the risk of relapse after successful cancer treatment and to precisely tailor further therapy accordingly. The researchers now want to rigorously examine the diagnostic method in a large clinical study involving 60 hospitals and develop standards for harmonized use of the MRD technology. "In this way, we aim to demonstrate the clinical, personal, and societal impacts of MRD-guided therapy", emphasizes Professor Heuser.

Establishing MRD as the gold standard

MRD assessment based on flow cytometry will then be introduced as quickly as possible across Europe as the golden standard for personalized management of leukemia treatment. To achieve this, the researchers are utilizing existing infrastructures for laboratories and clinics as well as expertise from European research networks for CLL ("ERIC") and for AML ("ELN-DAVID"). In addition, representatives from politics, patient organizations, nursing, social sciences, and health economics are being involved. "We aim to create a platform for clinical routine that assists medical personnel in determining the individual risk of relapse for AML and CLL patients and avoiding overtreatment," emphasizes Professor Heuser. This is intended to ensure that all patients throughout Europe have access to this test within their national healthcare systems.
The RESOLVE project (Residual disease assessment in hematologic malignancies to improve patient-relevant outcomes across Europe) is part of the "EU Mission on Cancer" funding line, with which the European Union supports projects that aim to improve the lives of more than three million people with cancer by 2030. In addition to ORTEC Clinical Care & Research, 20 other institutions and 60 hospitals from France, Germany, Greece, Israel, Italy, Poland, Spain, and The Netherlands are involved.
More information on the project RESOLVE can be found here.

About ORTEC Clinical Care & Research

ORTEC is a leading data science company and expert in combining domain substantive knowledge, mathematics and IT. ORTEC has a substantial footprint in solving complex problems applying data science, including AI, understanding the importance of good quality data, especially in healthcare. The ORTEC Clinical Care & Research department is specialized in providing software as a medical device for clinical decision support and its LogiqSuite Medical Data Management System used for cloud-based patient data storage in care settings or as an eCRF in trials. ORTEC CC&R supports multiple research consortia in building their registries. ORTEC's main contribution to RESOLVE is the delivery and configuration of the eCRF LogiqSuite.