Burkitt Lymphoma (BL)), Diffuse Large B Lymphoma (DLBCL), Follicular Lymphoma (FL), Hodgkin's Lymphoma (HL), Mantle Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), T-cell Lymphoma (T-NHL)
Conditions
Keywords
lymphoma, real life, cohort, epidemiology, PRO
Brief summary
REALYSA cohort is a population-based epidemiological platform in real-life for lymphomas designed to enrich prognostic data, by integrating together epidemiological, clinical and biological data. REALYSA is a platform perfectly set up to * Study prognostic factors using integrated epidemiological and biological data (genetics), to better characterize the determinants of refractoriness and relapse in patients with lymphoma, to follow the growing number of survivors and describe median to long-term sequela, second cancer, quality of life (QoL)… * Document treatment effectiveness in real life and observance * Address socio-economical questions
Interventions
The REALYSA database will be described with the following characteristics: * Number of patients included per month in total and according to subtype of lymphoma * Number of patients in each region in total and according to subtype of lymphoma
Sponsors
Study design
Eligibility
Inclusion criteria
* Signature of the consent form for participation in the REALYSA cohort * Aged over 18 at the time of inclusion * Diagnosed with lymphoma in the last 6 months (180 days) * Lymphoma subtype belonging to at least one of the 7 histological subtypes: diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, T-cell lymphoma, Hodgkin's lymphoma, Burkitt lymphoma
Exclusion criteria
* Anti-lymphoma treatment already received (except pre-phase: typically corticosteroids, vincristine, cyclophosphamide, etoposide, alone or in combination) * Documented HIV infection * Any other lymphoma subtype not included in the list in Appendix 1. Of note, are excluded: * Chronic lymphocytic leukemia/small lymphocytic lymphoma * Hairy cell leukemia and variant * Lymphoplasmacytic lymphoma * Waldenström macroglobulinemia * Primary DLBCL of the central nervous system (CNS) * T-cell large granular lymphocytic leukemia * Chronic lymphoproliferative disorder of NK cells * Mycosis fungoides * Sézary syndrome * Primary cutaneous T cell lymphomas (mainly diagnosed and treated by dermatologists) * Post-transplant lymphoproliferative disorders (PTLD)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients included per month in total and according to subtype of lymphoma | 5 years |
| Number of patients in each region in total and according to subtype of lymphoma | 9 years |
| Progression-Free Survival (PFS) | 9 years |
| Event-Free Survival (EFS) | 5 years |
| Overall Survival (OS) | 5 years |
| Net Survival | 5 years |
| Response rate | 5 years |
| Time to Next Anti-Lymphoma Treatment (TTNLT) | 5 years |
| Duration of Survival after progression | 5 years |
| Frequency of Lymphoma transformations | 5 years |
| Frequency of Second cancers | 5 years |
| Frequency of other chronic disease | 5 years |
| Number of exposure factors | Baseline |
| Number of comorbidities | Baseline |
| Duration of response | 5 years |
Other
| Measure | Time frame | Description |
|---|---|---|
| Representativeness of the included population | 5 years | Study population must show a good representativeness of the source population regarding demographic or diseases characteristics, to be able to generalize our results. Indeed, the representativeness of the study population can only be evaluated in areas covered by population-based cancer registries (PBCR) by comparing cases included in the REALYSA project to incident lymphoma cases registered in the general population (PBCR of the FRANCIM network). |
Countries
France