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 ReCLASS MZL, involves patients who have marginal zone lymphoma.
Why is this study being implemented?
Marginal zone lymphomas include several subtypes: extranodal marginal zone lymphoma, splenic marginal zone lymphoma, lymph node marginal zone lymphoma and, in some classifications, disseminated marginal zone lymphoma. There are different classifications of marginal zone lymphomas in the medical literature, not all of which agree on the definitions of the different subtypes. This makes research on these lymphomas more complex for clinicians and pathologists.
In addition, the method currently used to determine the stage of lymphoma is regularly criticized, as not suitable for lymphomas of the marginal zone.
What are the objectives of this study?
The study aims first of all to compare the existing classifications and staging method and to assess their impact on the evolution of lymphomas. It also aims to propose a new simplified approach that can be easier to use for clinicians, in particular to decide on the most appropriate management methods for patients.
How will the study be carried out?
The 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.
This study is being carried out by Dr. Côme Bommier, a physician at the Saint-Louis Hospital in Paris (AP-HP). He will have access to data on all patients with marginal zone lymphoma who participate in the REALYSA study.
The data analyzed in this study will not make it possible to establish a link with the identity of the patients, because they are pseudonymized: the first and last names of each person are replaced by a unique number assigned when included in REALYSA. LYSARC and its partners cannot link this number to a patient’s identity.
The ReCLASS MZL study is scheduled to begin in February 2025.
What does the study mean for you?
If you agree to have your data used for the study, this 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 do you need to 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.