REal World Data in LYmphoma and Survival in Adults
REALYSA
REAL WORLD DATA IN LYMPHOMA AND SURVIVAL IN ADULTS
2 other identifiers
observational
6,000
1 country
37
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Longer than P75 for all trials
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2018
CompletedStudy Start
First participant enrolled
November 14, 2018
CompletedFirst Posted
Study publicly available on registry
March 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 14, 2027
June 28, 2021
June 1, 2021
9 years
August 16, 2018
June 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
5 years
Secondary Outcomes (25)
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
- +20 more secondary outcomes
Other Outcomes (2)
Representativeness of the included population
5 years
Representativeness of the included population
9 years
Study Arms (1)
All enrolled patients
All patient who signed the consent form for participation to the study
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
Eligibility Criteria
Patients diagnosed with lymphoma in the last 6 months.
You may qualify if:
- Signature of the consent form for participation in the REALYSA cohort
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Unité d'Hématologie Clinique, CH D'ARRAS
Arras, 62022, France
Service d'Hématologie, CHU Jean Minjoz
Besançon, 25030, France
Service d'Onco-radiolothérapie, Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300, France
Institut Bergonié
Bordeaux, France
Centre Hospitalier Pierre Oudot
Bourgoin, 38302, France
Service d'Hématologie, Institut d'Hématologie de Basse Normandie
Caen, 14000, France
METROPOLE SAVOIE - SITE CHAMBERY, place Lucien Biset,
Chambéry, 73000, France
Service d'Hématologie Clinique et de Thérapie Cellulaire, Hôpital Estaing, CHU de Clermont-Ferrand
Clermont-Ferrand, 63000, France
Unité Hémopathies Lymphoïdes, Hôpital Henri Mondor
Créteil, 94010, France
CHU Francois MITTERRAND
Dijon, France
Service Hématologie, Centre Hospitalier de Dunkerque
Dunkirk, 59140, France
Service Oncologie médicale, Groupe Hospitalier Mutualiste de Grenoble, Institut Daniel Hollard,
Grenoble, 38028, France
CHD Vendée
La Roche-sur-Yon, France
Service d'Hématologie Clinique, Centre Hospitalier Universitaire Michallon
La Tronche, 38700, France
Clinique Victor Hugo
Le Mans, 72000, France
Centre hospitalier Libourne
Libourne, 33500, France
Service Oncologie médicale, HOPITAL SAINT VINCENT-DE-PAUL
Lille, 59020, France
Service des maladies du sang, Hôpital Claude Huriez, CHRU de Lille
Lille, 59037, France
Service Hématologie Clinique et Thérapie Cellulaire, CHU DE LIMOGES - HOPITAL DUPUYTREN,
Limoges, 87042, France
Département d'Hématologie et Oncologie, Centre Léon Bérard
Lyon, 69008, France
Département d'Hématologie Clinique, Hôpital Saint-Eloi,
Montpellier, 34295, France
Service Hématologie, GH REGION MULHOUSE ET SUD ALSACE - HOPITAL EMILE MULLER,
Mulhouse, 68070, France
Service d'Hématologie clinique, Centre Hospitalier Universitaire de Nantes
Nantes, 44093, France
Centre Hospitalier de Niort
Niort, 79021, France
Service Hématologie, Hôpital St Louis
Paris, 75475, France
CHU Haut-Lévêque
Pessac, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Service d'Hématologie et Thérapie Cellulaire, Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021, France
Hématologie Clinique, CHU PONTCHAILLOU
Rennes, 35033, France
Service Hématologie, Centre Hospitalier de Roubaix - Hôpital Victor Provo
Roubaix, 59056, France
Service Hématologie, UNIVERSITE DE ROUEN, CENTRE HENRI BECQUEREL
Rouen, 76038, France
Service Hématologie, CH YVES LE FOLL
Saint-Brieuc, 22027, France
Service Hématologie, Institut Curie - Hôpital René HUGUENIN
Saint-Cloud, 92210, France
Département d'Hématologie Clinique et Thérapie Cellulaire, Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42270, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Institut Universitaire du Cancer
Toulouse, France
Hématologie Clinique, CH DE BRETAGNE ATLANTIQUE
Vannes, 56017, France
Related Publications (2)
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, Fitoussi O, Detourmignies L, Abraham J, Soussain C, Lachenal F, Pica GM, Fogarty P, Cony-Makhoul P, Bernier A, Le Guyader-Peyrou S, Monnereau A, Boissard F, Rossi C, Camus V. Challenges for quality and utilization of real-world data for diffuse large B-cell lymphoma in REALYSA, a LYSA cohort. Blood Adv. 2024 Jan 23;8(2):296-308. doi: 10.1182/bloodadvances.2023010798.
PMID: 37874913DERIVEDGhesquieres 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 epidemiological, clinical, biological and treatment information to improve knowledge on lymphoma patients: study protocol of the "REal world dAta in LYmphoma and survival in adults" (REALYSA) cohort. BMC Public Health. 2021 Mar 2;21(1):432. doi: 10.1186/s12889-021-10433-4.
PMID: 33653294DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hervé Ghesquières, MD
Hospices Civils de Lyon
- STUDY DIRECTOR
Alain Monnereau, MD
Université de Bordeaux : Inserm
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 9 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2018
First Posted
March 11, 2019
Study Start
November 14, 2018
Primary Completion (Estimated)
November 14, 2027
Study Completion (Estimated)
November 14, 2027
Last Updated
June 28, 2021
Record last verified: 2021-06