REal World Data in LYmphoma and Survival in Adults

Study Overview
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Brief Summary
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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

Official Title
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REAL WORLD DATA IN LYMPHOMA AND SURVIVAL IN ADULTS

Conditions
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Diffuse Large B Lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), T-cell Lymphoma (T-NHL), Hodgkin's Lymphoma (HL), Burkitt Lymphoma (BL))

Intervention / Treatment
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* Other: Real-life epidemiological platform of lymphoma in France


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All enrolled patients<br>All patient who signed the consent form for participation to the study | Other: Real-life epidemiological platform of lymphoma in France<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| Event-Free Survival (EFS) |  | 9 years | 
| Overall Survival (OS) |  | 5 years | 
| Overall Survival (OS) |  | 9 years | 
| Net Survival |  | 5 years | 
| Net Survival |  | 9 years | 
| Response rate |  | 5 years | 
| Response rate |  | 9 years | 
| Duration of response |  | 5 years | 
| Duration of response |  | 9 years | 
| Time to Next Anti-Lymphoma Treatment (TTNLT) |  | 5 years | 
| Time to Next Anti-Lymphoma Treatment (TTNLT) |  | 9 years | 
| Duration of Survival after progression |  | 5 years | 
| Duration of Survival after progression |  | 9 years | 
| Frequency of Lymphoma transformations |  | 5 years | 
| Frequency of Lymphoma transformations |  | 9 years | 
| Frequency of Second cancers |  | 5 years | 
| Frequency of Second cancers |  | 9 years | 
| Frequency of other chronic disease |  | 5 years | 
| Frequency of other chronic disease |  | 9 years | 
| Number of exposure factors |  | Baseline | 
| Number of comorbidities |  | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymphoma, real life, cohort, epidemiology, PRO