The REALYSA study aims to improve knowledge about lymphomas and the lives of patients with lymphoma. 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 concerns all patients participating in the study and mainly aims to study the impact of other present or past diseases on the evolution of lymphoma.
Why is this study being implemented?
The evolution of therapies in the field of lymphomas makes it possible to treat increasingly older patients. As a result, the patient population is increasingly varied, especially with regard to other diseases that patients may have (or have had), which are called comorbidities (chronic pathologies, other cancers, etc.).
It is extremely important to better document these comorbidities. They can have consequences on the adverse effects and effectiveness of treatments. The purpose of this study is therefore to improve the care of patients with lymphomas by better understanding the impact of their comorbidities.
This study is carried out at the initiative of LYSARC (data controller) and implemented by the company PELyon, located at 210 Avenue Jean Jaurès, 69007 Lyon (implementation manager), which will be the recipient of the personal health data processed as part of the study
What are the objectives of the study?
The main objective of this study is to describe the presence and impact of other diseases that you may have (or have had) on the evolution of your lymphoma based on REALYSA data linked to health insurance data (data present in the SNDS – National Health Data System).
This project also aims to estimate the consumption of care and the costs related to the management of lymphomas at the national level. Finally, this study will allow analyses to be conducted to assess the quality of REALYSA’s data.
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 as part of this study. This project also requires data that is not available in the REALYSA database. This data exists in your medical file in your care centre, but also in the national databases that allow the reimbursement of care provided in hospitals (via the SNDS: portal of the National Health Data System).
In order to be able to meet the scientific objectives of this study, we will link your data collected within REALYSA to your care data collected by the Health Insurance and recorded in the SNDS, via an indirect matching: for each patient participating in REALYSA, we will try to find him or her within the national database of the SNDS, using data relating to their age, sex, diagnosis, dates and types of care received to identify them. This is called indirect matching because there is no unique patient identifier present in both databases (the Social Security number is not collected in REALYSA).
As one of the objectives of this study is to describe the representativeness of REALYSA in relation to all lymphoma patients identified within the SNDS, your data (from the SNDS) may be concerned by this study even if you do not participate in REALYSA. In addition, a control cohort made up of patients who do not have lymphoma but whose characteristics are similar to those of REALYSA patients will also be set up in order to answer the question of the consumption of care specifically attributable to lymphoma.
The rights in relation to your personal data are then similar to those of the patients participating in REALYSA described below.
In addition, no data from the SNDS can be recorded in REALYSA. The data will remain on the secure server of the SNDS and will only be used to meet the objectives presented above. As with all REALYSA data concerning you, this data will only be accessible to authorised researchers.
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.
This study is scheduled to begin in Q2 2025. All patients participating in REALYSA are concerned by this analysis. The data studied in the national database of the SNDS will extend from 1st January 2013 to 31 December 2028.
Access to REALYSA data and data from the SNDS will be effective for PELyon for a maximum of 3 years from the date of their availability. No copies of the data will be kept beyond this period.
This study is led by Prof. Hervé Ghesquières, a doctor at the Lyon Sud Hospital. He will have access to data on all patients participating in the REALYSA study. The statistical analyses on the matched data will be carried out by two biostatisticians from PELyon, a LYSARC partner and specialist in real-life studies, based mainly on SNDS data. These people are authorised to work on the data from these national databases.
The processing of personal health data implemented in this study is necessary for the performance of a mission of public interest entrusted to LYSARC in its capacity as data controller, the legal basis for the processing pursuant to Article 6-1-e) of the GDPR, as well as for scientific research purposes as defined in Article 9-2-j) of the GDPR.
Attention patients participating in REALYSA and patients whose SNDS data could be used for the study
What does this project means for you?
This study concerns all patients included in REALYSA, as well as all patients selected in the SNDS (patients with lymphomas and patients without lymphoma constituting the control group) over the period 2013-2028.
If you agree to have your data used for this study, this has no direct implications for you. In particular, you will not have to answer any additional questionnaires, and no additional deduction will be necessary in relation to what is already planned as part of your participation in REALYSA. If you do not participate in REALYSA, the use of your data from the SNDS will also have no direct implications for you.
What should you do about this study?
- –>You are not opposed to the use of your data in the context of this study:
- In this case, no action is required on your end.
- –>You would like to object to the use of your data in the context of this study. Two situations are then possible:
Case 1: You participate in the REALYSA study
In this case, you must inform the doctor who suggested that 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 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.
Case 2: You do not participate in the REALYSA study
In this case, you have the right to access all the data collected about you and, if necessary, to request rectification if your data is found to be inaccurate, to complete it if it is incomplete, or to limit it if the collection of certain data is not justified.
You also have the right to object to the transmission and use of data covered by professional secrecy. Exercising this right to object will result in the termination of your participation in the study.
These rights can be exercised at any time by contacting LYSARC’s Data Protection Officer:
- by email to dpo@lysarc.org or
- by mail to the attention of the Data Protection Officer, LYSARC – Centre Hospitalier Lyon-Sud – Bâtiment 2D, 69495 PIERRE-BÉNITE Cedex
If you believe, after contacting the LYSARC DPO, that your rights over your data are not respected, you can submit a complaint to the CNIL:
https ://www.cnil.fr/fr/webform/adresser-une-plainte
If you need to withdraw from the study and wish to exercise your right to erasure of your data, the Data Controller may, pursuant to Articles 17.3.c and 17.3.d. of the GDPR, not grant this request if it is likely to make impossible or seriously compromise the achievement of the objectives of the study. Thus, your data collected prior to the withdrawal of your consent may not be erased and may continue to be processed under the conditions provided for by the research. After you withdraw from the study, no new data will be collected.