The REALYSA study aims to improve knowledge about lymphomas and the lives of lymphoma patients. Thus, it allows for many sub-studies on specific research questions. One of these substudies, called POLARYSA, involves diffuse large B-cell lymphomas
Why is this study implemented?
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin’s lymphoma. Approximately 40% of patients in the REALYSA cohort are diagnosed with this type of lymphoma. One of the goals of REALYSA is to better understand the demographic and clinical characteristics of adult patients with lymphoma in France, and to describe the treatments they receive and how they respond to them.The POLARYSA study will focus on patients participating to REALYSA who have been diagnosed with DLBCL. Several analyses are planned as part of this project. Initial results will be available during the course of 2022.
These “real life” data, collected outside of a clinical trial setting, are not yet available in France, and will therefore be useful to a wide range of stakeholders involved in the management of these diseases, for the benefit of patients.
How will this study be conducted?
This study is based on the analysis of data from the medical records of patients participating in REALYSA and questionnaires already completed by these patients. These analyses will be carried out by members of LYSARC.
The POLARYSA project is carried out in collaboration with Roche, partner of the REALYSA study. Roche will have access to the aggregated and anonymized results of this study, but there will not be any transfer of individual data to the laboratory : No link can be made between the data contained in the reports and the patients participating in REALYSA.
Several data extractions are planned for 3 distinct analyses : in November 2021; november 2023 and during 2029.
For patients participating in REALYSA
What does this study mean for you?
This study is only for patients participating in REALYSA who have diffuse large B-cell lymphoma.
If you are in this situation and you agree that your data be 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:
- 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 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.