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 such substudy, called ELKIN, involved Hodgkin lymphomas in patients over the age of 60.
Why is the ELKIN study being implemented?
While almost all young patients with Hodgkin’s lymphoma are cured by conventional chemotherapy, the course of the disease under treatment is significantly less favorable in patients over 60 years of age. Intriguingly, among elderly patients with Hodgkin’s lymphoma (but not in younger patients), those who are carriers of the Epstein-Barr virus (a virus that is part of the large family of herpes viruses) have a disease that progresses even more unfavorably (according to a study published in 2005). The biological reasons for this phenomenon are not yet understood.
What are the objectives of the ELKIN study?
The objective of this project is to analyze the genetic data of tumor cells in order to identify categories of patients with a worse prognosis. Until recently, these genetic analyses were not possible in Hodgkin lymphoma because there are very few tumour cells within tumours. Recently, research has shown that the DNA of these tumor cells circulates in the blood and that it can be identified (indeed, tumor cells have a different DNA than normal cells) thanks to new sophisticated technologies developed in the USA at Stanford University. The study will make it possible to analyze the impact of certain mutations in this tumor DNA, in connection with the presence or absence of the Epstein-Barr virus, on the evolution of the disease.
How will the ELKIN study be conducted?
The ELKIN study is based on the analysis of data from the medical records of patients participating in REALYSA and the analysis of biological samples taken during their follow-up in REALYSA.
This study is carried out by Dr. Rossi, a doctor at Dijon University Hospital, currently working in a laboratory at Stanford University (USA) specializing in tumor DNA analysis. The biological analyses will be carried out by Dr. Rossi and the statistical analyses will be carried out in close collaboration with members of LYSARC.
Dr. Rossi will have access to data on all Hodgkin lymphoma patients over the age of 60 participating in the REALYSA study. These data will not make it possible to establish a link with the identity of the patients because they are pseudonymized: the name and surname of each person are replaced by a unique number assigned during inclusion in REALYSA. LYSARC and its partners cannot link this number to a patient’s identity.
The ELKIN study is scheduled to begin in June 2023.
A l’attention des patients participant à REALYSA
What does the ELKIN study mean for you?
This study is only for patients participating in REALYSA who have Hodgkin’s lymphoma and were 60 years of age or older at diagnosis.
If you are in this situation and you agree to your data being used for this study, this has no direct implication for you.
Compared to what is already planned as part of your participation in REALYSA, you will not have to answer any additional questionnaire and you will not have any additional biological samples.
What should you do about the ELKIN study?
There are two options:
- You do not object to the use of your data and samples in the context of the ELKIN 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 the ELKIN 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.