The 3000th patient included in REALYSA – A unique cohort in France, ready for its first research projects on lymphoma

The REALYSA cohort

REALYSA stands for “REal world dAta in LYmphomas and Survival in Adults”. It is a study in real-world settings, gathering epidemiological, clinical and biological data on adult lymphoma patients in France. REALYSA Principal Investigators are Pr Hervé Ghesquières, haematologist at the Hospital Lyon-Sud (Hospices Civils de Lyon) and Dr Alain Monnereau, researcher at EPICENE (Bordeaux), who coordinates the epidemiological side of the study. Since the launch of the study in November 2018, more than 3,000 patients have been enrolled in 35 care structures throughout the French metropolitan territory.

Which research projects are taking place with REALYSA?

A lot of data is collected in this study and will help produce important results on these complex diseases. Data is collected at the time of diagnosis and then on a regular basis throughout the patients’ participation in the study. All this information will be used for various research projects to get a better understanding of, among other things, the profile of lymphoma patients, the disease management provided in daily practice in France, and factors associated with the occurrence of lymphoma and the response to treatment. Several projects are currently underway building on the opportunities offered by the cohort that was initiated in 2018, benefiting from the increasing amount of consolidated data available.

For instance, a first analysis is being carried out end of 2021 in order to better understand the profile of patients with diffuse large B-cell lymphoma (DLBCL), the most common type of lymphoma. DLBCL patients represent approximately 40% of the patients in REALYSA . This analysis should help improve our understanding of the disease management these patients received in haematology departments across France, and how they respond to treatments. The results of this analysis will provide valuable information to the entire scientific and medical community to improve the management of these patients in the future. The results of this analysis will be published at an upcoming medical congress. This analysis is realised in partnership with Roche.

In addition, data on patients’ quality of life and their experience with the disease is collected during the study. This information will be carefully analysed to gain a better understanding of patients’ quality of life during the course of the disease and the factors associated with this quality of life. This study should allow the earlier identification of patients who are more at risk of having a deteriorated quality of life after their diagnosis, in order to propose specific interventions to improve their life with the disease. This research project benefits from a financial support from the French National Cancer Institute (INCa).

Other research projects are being developed, including projects on the epidemiological data and on the biological samples of REALYSA patients.

How many patients will be included in REALYSA in total?

The study will follow 6000 patients to get more insight and help produce new and reliable results on the effectiveness of drugs in real life settings (outside of clinical trials), factors associated with response to treatment, care pathways and patients’ experiences. The REALYSA study is now well integrated in the different haematology departments where it can be offered, and about 160 new patients per month agree to join the cohort. Thus, with the recent inclusion of the 3000th patient, half of the recruitment has been done! At the current rate, it is expected that the 6000th patient will be included in REALYSA in the course of 2023. Once the inclusions are complete, the follow-up phase will continue for all patients until the end of 2028.