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 these substudies, called SynthEID, involves patients aged 80 years and older who have diffuse large B-cell lymphoma. This study aims to improve the research for new treatments for these patients.
Why is the SynthEID study being implemented?
Although there is an effective standard treatment for a majority of elderly patients with a diffuse large B-cell lymphoma, the search for new treatments remains essential. Several therapeutic strategies are being developed for these patients. In order to be able to identify the most promising strategies as early as possible, it is necessary to develop new research methods. This is the goal of the SynthEID study.
In traditional clinical trials, two groups of patients are formed: patients receive in the first group an experimental treatment, in the second group the reference treatment (also called “control”). It is the comparison between the two groups that makes it possible to know whether the experimental treatment provides an advantage over the reference treatment.
However, these traditional trials take a long time to complete. In order to move faster, the researchers are developing a new way of doing things: to build a single group of patients, receiving the experimental treatment, and compare it to a group of patients participating or having participated in other trials or studies. This control group is called “synthetic”.
To build this “synthetic” control group, researchers use data from patients who have participated in completed trials or who are being followed in studies such as REALYSA. These patients are selected so that the “synthetic” control group resembles as closely as possible the group of patients receiving the experimental treatment. Thus, the comparison between the two groups can be made more quickly.
What are the objectives of the SynthEID study?
The objective of this study is to develop the method for forming “synthetic” control groups of patients aged 80 years and older who have diffuse large B-cell lymphoma.
These “synthetic” control groups can thus be created and used as a point of comparison in various ongoing or future trials. It will make it possible to know which therapeutic strategies evaluated in these trials are the most interesting.
How will the SynthEID study be conducted?
The SynthEID study will be based on the analysis of data from the medical records of patients participating in REALYSA or having participated in various clinical trials conducted by LYSA.
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 SynthEID study is carried out by Dr. Benoît Tessoulin, hematologist at Nantes University Hospital.
The study is scheduled to begin in February 2023.
For patients participating in REALYSA
What does the SynthEID study mean for you?
This study is only for patients participating in REALYSA who have diffuse large B cell lymphoma and are 80 years of age and older.
If you are in this situation and you agree that your data is being 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 the SynthEID study?
There are two options:
- You are not opposed to the use of your data and samples in the context of study SynthEID:
- In this case, you don’t have to do anything
- You wish to object to the use of your data in the context of study SynthEID:
- 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.