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 these sub-studies is mantle cell lymphomas.
Why is this study being implemented?
Mantle cell lymphoma is a rare cancer of the blood that affects a particular type of white blood cell called B cells. Its course can vary from person to person: some forms require quick treatment, while others progress more slowly and can sometimes be monitored for a while before treating.
Thanks to advances in research and the arrival of new treatments, the management of mantle cell lymphoma has improved significantly in recent years. Many people are now living longer with the disease. However, it can reappear after treatment and require different management over time, adapted to each situation.
In this context of therapeutic progress, the quality of life of patients becomes an essential element of care. This means that doctors are interested not only in the effectiveness of treatments, but also in how illness and care impact daily life, fatigue, pain, morale or the ability to lead a normal life.
However, there is limited information available on the quality of life of people with mantle cell lymphoma . Most of the data comes from clinical trials, which don’t always reflect the diversity of patients in real life.
This is why the REALYSA programme is very important. It allows patients to be followed in their real care pathway, to better understand how their quality of life evolves over time and what factors may influence it. This knowledge will help to better adapt care and improve the daily lives of people living with mantle cell lymphoma .
Researchers believe that the quality of life of patients with mantle cell lymphoma does not evolve in the same way for everyone. It could be influenced by several elements, such as:
- the characteristics of the disease,
- the results of the biological examinations,
- the type of treatment received,
- or the psychological and social context.
What are the objectives of the study?
The study aims to identify the factors that influence the quality of life of patients with mantle cell lymphoma, using data collected from the REALYSA cohort. It will also describe how quality of life evolves at different points during follow‑up, and it will allow comparisons of quality of life according to the treatments received.
How will the study be carried out?
This study will be based on the analysis of data from the medical records of patients participating in REALYSA and the questionnaires already completed by these patients (in particular the quality of life and social support questionnaires).
This study is carried out by Prof. Maynadié and Dr. Tayou of the Dijon University Hospital, in conjunction with Prof. Carras of the Grenoble University Hospital. They will have access to data on all patients with mantle cell lymphoma participating in the REALYSA study. This data will not make it possible to establish a link with the identity of the patients because it is pseudonymised: the first and last names of each person are replaced by a unique number assigned when they are included in REALYSA. LYSARC and its partners cannot link this number to a patient’s identity.
The study is scheduled to begin in March 2026.
TO THE ATTENTION OF PATIENTS PARTICIPATING IN REALYSA
What does the INTENSIFY study mean for you?
This study is only for patients participating in REALYSA who have mantle cell lymphoma.
If you are in this situation and you agree to have your data used for this study, it has no direct implications 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:
- You are not opposed to the use of your data in the context of this study:
- In this case, you don’t have to do anything.
- You wish to object to the use of your data in the context of this study:
- In this case, you must inform the doctor who offered you to 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 on your rights to object to the use of your data on page 12 of the information notice that was given to you when you agreed to participate in REALYSA.
We remind you that you can object to the use of your data and/or biological samples at any time without this having any impact on your care or participation in the study.