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 ReA-GiP, aims to assess representativeness, in Poitou-Charentes area, of the real-life REALYSA cohort versus the population-based registry of the General Cancer Registry * of Poitou Charentes.
*The Poitou Charentes General Cancer Registry is a structure that continuously records health data related to cancers.
Why is the ReA-GiP study implemented?
An important dimension of the REALYSA cohort is to be representative of whole population of patients who receive a diagnosis of lymphoma during the same period in France.
The cohort representativeness may for instance be impacted by the representativeness of the centers (university hospitals, small hospitals, etc.) where REALYSA participants are included, compared to all French centers where people diagnosed with lymphoma may be treated. Other difficulties in the care centers, for example to include elderly patients or patients who are very ill, can impact the representativeness of the cohort.
The ReA-GiP study was set up to compare patients enrolled in REALYSA with patients registered in the Poitou-Charentes general cancer registry.
What are the objectives of the ReA-GiP study?
The objective of this study is to compare the prognostic and therapeutic characteristics of patients enrolled in the REALYSA study, in the Poitou-Charentes region, with those of patients included in the Poitou-Charentes general cancer registry. This project will thus provide information on the representativeness of REALYSA participants and help identify possible inclusion biases. This work complements the study that was carried out within the Haematology Department of Lyon Sud.
How will the ReA-GiP study be conducted?
The ReA-GiP study is based on the analysis of data from the medical records and questionnaires already completed of patients participating in REALYSA and diagnosed with one of the following 3 subtypes of lymphoma: Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL) or Hodgkin Lymphoma (HL) between January 1, 2021 and December 31, 2021 at the Hematology Departments of Poitiers and Niort. It also uses data from people not included in REALYSA and registered in the Poitou-Charentes general cancer registry for the diagnosis of one of the 3 lymphoma subtypes mentioned above (DLBLC, FL or HL), during the same period.
This study is carried out by Dr. Thomas SYSTCHENKO, hospital practitioner at Poitiers Hematology Department and doctoral student at the Poitou-Charentes general cancer registry. It has access to all the data of patients with DLBCL, FL or HL, whether or not included in REALYSA study between January 1, 2021, and December 31, 2021 throughout Poitou-Charentes (including the Haematology Departments of Poitiers and Niort).
It is not possible for LYSARC 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.
ReA-GiP study began in July 2023.
For patients participating in REALYSA
What does the ReA-GiP study mean for you?
This study is only for patients included in REALYSA in one of the two Poitou-Charentes region centers (Poitiers and Niort) for a diagnosis of a Diffuse Large B-cell lymphoma (DLBCL), Follicular Lymphoma (FL) or Hodgkin lymphoma (HL) between January 1, 2021 and December 31, 2021.
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 the ReA-GiP study?
There are two options:
- You are not opposed to the use of your data in the context of the ReA-GiP 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 ReA-GiP 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.