Recruiting NCT03869619
REal World Data in LYmphoma and Survival in Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Real-life epidemiological platform of lymphoma in France.
- Who it may be relevant to
- Registry conditions: Diffuse Large B Lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
REAL WORLD DATA IN LYMPHOMA AND SURVIVAL IN ADULTS
Overview
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
- Other Real-life epidemiological platform of lymphoma in France
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
Primary outcome measures
- Progression-Free Survival (PFS) [Time frame: 5 years]
Secondary outcome measures (12)
- Number of patients included per month in total and according to subtype of lymphoma [Time frame: 5 years]
- Number of patients in each region in total and according to subtype of lymphoma [Time frame: 9 years]
- Progression-Free Survival (PFS) [Time frame: 9 years]
- Event-Free Survival (EFS) [Time frame: 5 years]
- Event-Free Survival (EFS) [Time frame: 9 years]
- Overall Survival (OS) [Time frame: 5 years]
- Overall Survival (OS) [Time frame: 9 years]
- Net Survival [Time frame: 5 years]
- Net Survival [Time frame: 9 years]
- Response rate [Time frame: 5 years]
- Response rate [Time frame: 9 years]
- Duration of response [Time frame: 5 years]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 37 centers
- Unité d'Hématologie Clinique, CH D'ARRAS — Arras
- Service d'Hématologie, CHU Jean Minjoz — Besançon
- Service d'Onco-radiolothérapie, Polyclinique Bordeaux Nord Aquitaine — Bordeaux
- Institut Bergonié — Bordeaux
- Centre Hospitalier Pierre Oudot — Bourgoin
- Service d'Hématologie, Institut d'Hématologie de Basse Normandie — Caen
- METROPOLE SAVOIE - SITE CHAMBERY, place Lucien Biset, — Chambéry
- Service d'Hématologie Clinique et de Thérapie Cellulaire, Hôpital Estaing, CHU de Clermont — Clermont-Ferrand
- … and 29 more centers
Publications
- Ghesquieres H, Cherblanc F, Belot A, Micon S, Bouabdallah KK, Esnault C, Fornecker LM, Thokagevistk K, Bonjour M, Bijou F, Haioun C, Morineau N, Ysebaert L, Damaj G, Tessoulin B, Guidez S, Morschhauser F, Thieblemont C, Chauchet A, Gressin R, Jardin F, Fruchart C, Laboure G, Fouillet L, Lionne-Huyghe P, Bonnet A, Lebras L, Amorim S, Leyronnas C, Olivier G, Guieze R, Houot R, Launay V, Drenou B, Fi PMID 37874913
- Ghesquieres H, Rossi C, Cherblanc F, Le Guyader-Peyrou S, Bijou F, Sujobert P, Fabbro-Peray P, Bernier A, Belot A, Chartier L, Fornecker LM, Baldi I, Bouabdallah K, Laurent C, Oberic L, Morineau N, Le Gouill S, Morschhauser F, Haioun C, Damaj G, Guidez S, Laboure G, Fitoussi O, Lebras L, Gressin R, Salles G, Ysebaert L, Monnereau A. A French multicentric prospective prognostic cohort with epidemio PMID 33653294
Identifiers
NCT: NCT03869619 · 69HCL18_0352 · 2018-A01332-53