The REALYSA study aims to improve knowledge about lymphomas and the lives of patients with lymphomas. Thanks to the large number of patients who participate, it allows sub-studies to be conducted simultaneously on specific research questions. One of its sub-studies, called REALYSA-EBV, is in patients with EBV-positive large B-cell lymphoma.
Why is this study being implemented?
Epstein–Barr virus (EBV)–positive diffuse large B-cell lymphoma is a type of lymphoma characterized by the malignant proliferation of B cells infected with the Epstein–Barr virus (EBV). It is a rare entity that is treated using the same approaches as conventional diffuse large B-cell lymphoma.
A large study has been undertaken within the LYSA group to further characterize, at the biological (molecular) level, the cases included in previous clinical studies.
There is currently little precise information regarding the characteristics of patients and the treatments that are offered today in real-world practice. The REALYSA study will make it possible to obtain these data.
What are the objectives of the study?
The study aims to characterize these rare lymphomas at the molecular level and to correlate the molecular data with clinical information. Demographic data, as well as information on patients’ health status and its progression over time, will also be analyzed. The study also seeks to determine which treatments these patients have received and how effective these treatments have been. PET-CT scan images will likewise be analyzed in order to better understand how the disease evolves during treatment. The biological samples taken during your follow-up in REALYSA will also be analyzed.
These so-called “real-world” data (as opposed to clinical trial data) will be valuable for improving our understanding of how patients are managed and for identifying areas where care may be improved. They will therefore contribute to the development of improved therapeutic protocols in the future.
How will the study be carried out?
The study will be based on the analysis of data from the medical records and of biological samples of patients participating in REALYSA. These analyses will be carried out by members of LYSARC.
This study is carried out in collaboration with Prof. Clémentine Sarkozy (Institut Curie) and Dr. Estelle Bourbon (Hospices Civils de Lyon). No link can be made between the data contained in the reports and the patients participating in REALYSA.
The study will begin in March 2026.
TO THE ATTENTION OF PATIENTS PARTICIPATING IN REALYSA
What does this study mean for you?
This study only concerns patients participating in REALYSA who have EBV-positive large B-cell lymphoma.
If you are in this situation and you agree to your data being used for this study, this has no direct implication for you.
In particular, you will not have to answer any additional questionnaire compared to what is already planned as part of your participation in REALYSA.
What should you do about this study?
There are two options:
1- You do not object to the use of your data in the context of the study:
– In this case, you don’t have to do anything
2- You wish to object to the use of your data in the context of the study:
– In this case, you must inform the doctor who suggested you participate in the REALYSA study. You can also notify your decision by writing an email to the following address: dpo@lysarc.org .
You will find detailed information about your rights to object to the use of your data on page 12 of the information provided to you when you agreed to participate in REALYSA.