1000th patient included in REALYSA
On Friday 28th of August 2020, in the University Hospital Center of Dijon, the 1000th patient was recruited in REALYSA. We would like to thank all the clinical research departments involved in this study, and all the patients who placed their trust in us. This ambitious study aims to follow 6000 newly diagnosed lymphoma patients for a maximum of 9 years, in order to improve knowledge about these complex diseases and to better understand the patient care pathway, the effectiveness of treatments and the events occurring after the disease.
REALYSA – whose acronym stands for “REal world dAta in LYmphomas and Survival in Adults” – is a real life study of adult patients with lymphoma in France, including epidemiological, clinical and biological data. Since the launch of the study in November 2018, 1000 patients have already been recruited in 15 centers across France! “Many hematology departments are committed across France to recruit patients in this study. We would like to thank everyone, clinical research departments and patients, for this great general mobilization!”, adds Pr Hervé Ghesquières, hematologist at Lyon-Sud Hospital – Hospices Civils de Lyon and coordinating investigator of the study.
What is the point of conducting this study?
Despite improvements in lymphoma management since the early 2000s, the reasons why some patients respond well to treatment and others relapse are still poorly understood. “We still know very little about the factors (environmental or social) associated with the response to treatment and the survival of patients,” explains Dr Alain Monnereau, epidemiologist at the National Institute of Health and Medical Research (Inserm) in Bordeaux, and coordinating investigator of the epidemiological part of the study. In addition, there is very little real-life data, most of the data currently coming from clinical trials. Only 10-15% of lymphoma patients participate in clinical trials, resulting in a significant loss of information for the vast majority of patients. Moreover, certain populations are very poorly represented in the trials, such as very elderly patients or patients with heart problems, for example. Being able to supplement clinical trial data with real-life study data is critical.
Focus: what does “real life study” mean?
In a real-life study, data on usual clinical care is collected without any intervention. Data is generated during routine patient care. Real-life studies are complementary to classic clinical studies because they allow the collection of information on current healthcare practices in a patient population comparable to the general patient population.
What is the goal of REALYSA?
Set up by LYSA and led by LYSARC, in collaboration with the Hospices Civils de Lyon, Inserm and the network of population-based cancer registries FRANCIM, REALYSA aims to follow 6000 adult patients newly diagnosed with lymphoma, with a follow-up of up to 9 years. A great amount of epidemiological and clinical data will be collected upon inclusion in the study and during follow-up.
This ambitious and innovative study will improve knowledge on many topics related to lymphoma, such as:
– the factors involved in the progression of the disease: personal, medical, environmental factors, treatments, surveillance ;
– elements that could contribute to the disease onset ;
– long-term side effects of treatments ;
– the repercussions of lymphoma and its treatments on the quality of life relating to the health, personal, family, professional and social life of patients.
For example, this study could identify a correlation between having been exposed to pesticides in the professional life and the fact of responding less well to lymphoma treatment. Another example: this study will provide a better understanding of the impact of treatments on the quality of life of patients. “REALYSA is a unique opportunity in France to learn more about lymphomas, including the role of the patients’ personal and professional environment!” complete Dr Cédric Rossi, hematologist at the University Hospital Center of Dijon.
Finally, blood samples will be collected and stored for patients included in REALYSA and willing to donate blood. Biological studies will be carried out on these samples to analyze the influence of certain molecules or certain markers on the development of the disease, the response to treatment and the adverse effects associated with the treatment. In addition, genetic studies may also be carried out on these blood samples, to study the influence of certain genetic mutations or certain genetic profiles on patients’ response to treatment.
Thanks to this large-scale study, unique in France, a very rich database will be created, allowing the production of high-quality scientific data on many themes related to lymphoma.