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 is in patients aged 80 years and older with diffuse large B-cell lymphoma (DLBCL). This sub-study, called SENIO-IPI (SENIOR International Prognostic Index), aims to validate a prognostic score.
Why is this study being implemented?
Prognostic scores allow physicians to predict the likely course of lymphoma in a patient and, based on the result of this score, to propose an appropriate therapeutic strategy. Prognostic scores are developed by combining several factors related to the patient or the lymphoma. Until now, there has been no suitable prognostic score for patients with diffuse large B-cell lymphoma over the age of 80.
By combining data from 3 LYSARC clinical studies, a team developed a score specific to patients over 80 years of age, a score that is called SENIOR-IPI. It is now necessary to validate this new score with a large number of patients, which is what the REALYSA cohort allows.
.
What are the objectives of the study?
The study therefore aims to evaluate and validate the SENIOR-IPI prognostic score. The so-called “real-life” data (as opposed to clinical trials) obtained as part of the REALYSA cohort are adapted to validate this new score.
The validation of this new prognostic score will thus improve future therapeutic protocols for patients over 80 years of age.
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.
This study is carried out in collaboration by Dr. Jean-Philippe JAIS (Necker Hospital, AP-HP, Paris) and Dr. Sydney DUBOIS and Dr. Fabrice JARDIN (Henri Becquerel Hospital, Rouen). Dr. Jean-Philippe JAIS will carry out the analyses and will therefore have access to data on all patients aged 80 and over with diffuse large B-cell lymphoma and participating in REALYSA. 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.
The study is scheduled to start in May 2024.
TO THE ATTENTION OF PATIENTS PARTICIPATING IN REALYSA
What does this project implies for you?
This study is only for patients participating in REALYSA who have diffuse large B-cell lymphoma and who were 80 years of age or older at the time of diagnosis.
If you are in this situation and you agree to have your data used for this study, it 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 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 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.