The REALYSA study aims to improve knowledge about lymphomas and the lives of lymphoma patients. Thanks to the large number of patients involved, it allows sub-studies on specific research questions to be conducted simultaneously. One of his substudies, called REALMA, involves patients who have marginal zone lymphoma.
Why is the REALMA study being implemented?
Marginal zone lymphomas have three distinct subtypes: extranodal marginal zone lymphomas, splenic marginal zone lymphomas and lymph node marginal zone lymphomas. For each of these subtypes, there is no validated and referenced standard of care. In fact, the modalities of management of patient with marginal zone lymphoma may vary from one centre to another. This variability in medical practices is currently poorly understood.
What are the objectives of the REALMA study?
The REALMA study aims first to better understand the characteristics of adult patients with marginal zone lymphoma. It then aims to describe how these patients are cared for and what treatments are offered to them. Finally, it aims to collect information on the effectiveness of the different treatments received by patients.
How will the REALMA study be conducted?
The REALMA study will be based on the analysis of data from the medical records of patients participating in REALYSA and questionnaires already completed by these patients.
This study is carried out by Dr. Côme Bommier, a doctor at the Saint-Louis Hospital in Paris (AP-HP). It will have access to data on all marginal zone lymphoma patients participating in the REALYSA study.
It will not be possible to establish a link between the data and the identity of the patients because data are pseudonymized: the name and surname of each person are replaced by a unique number assigned at inclusion in REALYSA. LYSARC and its partners cannot link this number to a patient’s identity.
The REALMA study is scheduled to begin in February 2023.
For patients participating to REALYSA
What does the REALMA study mean for you?
If you agree to your data being used for the REALMA 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 the REALMA study?
There are two options:
- You do not object to the use of your data in the context of the REALMA study:
è In this case, you don’t have to do anything
- You wish to object to the use of your data in the context of the REALMA study:
è 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.