REal World Data in LYmphoma and Survival in Adults

Официальное название

REAL WORLD DATA IN LYMPHOMA AND SURVIVAL IN ADULTS

Обзор

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

Вмешательства

• Другое 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

Первичные конечные точки

• Progression-Free Survival (PFS) [Срок оценки: 5 years]

Вторичные конечные точки (12)

• Number of patients included per month in total and according to subtype of lymphoma [Срок оценки: 5 years]
• Number of patients in each region in total and according to subtype of lymphoma [Срок оценки: 9 years]
• Progression-Free Survival (PFS) [Срок оценки: 9 years]
• Event-Free Survival (EFS) [Срок оценки: 5 years]
• Event-Free Survival (EFS) [Срок оценки: 9 years]
• Overall Survival (OS) [Срок оценки: 5 years]
• Overall Survival (OS) [Срок оценки: 9 years]
• Net Survival [Срок оценки: 5 years]
• Net Survival [Срок оценки: 9 years]
• Response rate [Срок оценки: 5 years]
• Response rate [Срок оценки: 9 years]
• Duration of response [Срок оценки: 5 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 37 центров

• 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
• … и ещё 29 центров

Публикации

• 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

Идентификаторы

NCT: NCT03869619 · 69HCL18_0352 · 2018-A01332-53

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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