REal World Data in LYmphoma and Survival in Adults

NCT ID: NCT03869619

Last Updated: 2021-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-14

Study Completion Date

2027-11-14

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

Detailed Description

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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))

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All enrolled patients

All patient who signed the consent form for participation to the study

Real-life epidemiological platform of lymphoma in France

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Lymphoma Academic Research Organisation

OTHER

Sponsor Role collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hervé Ghesquières, MD

Role: STUDY_DIRECTOR

Hospices Civils de Lyon

Alain Monnereau, MD

Role: STUDY_DIRECTOR

Université de Bordeaux : Inserm

Locations

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Unité d'Hématologie Clinique, CH D'ARRAS

Arras, , France

Site Status RECRUITING

Service d'Hématologie, CHU Jean Minjoz

Besançon, , France

Site Status RECRUITING

Service d'Onco-radiolothérapie, Polyclinique Bordeaux Nord Aquitaine

Bordeaux, , France

Site Status RECRUITING

Institut Bergonié

Bordeaux, , France

Site Status RECRUITING

Centre Hospitalier Pierre Oudot

Bourgoin, , France

Site Status RECRUITING

Service d'Hématologie, Institut d'Hématologie de Basse Normandie

Caen, , France

Site Status RECRUITING

METROPOLE SAVOIE - SITE CHAMBERY, place Lucien Biset,

Chambéry, , France

Site Status RECRUITING

Service d'Hématologie Clinique et de Thérapie Cellulaire, Hôpital Estaing, CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Unité Hémopathies Lymphoïdes, Hôpital Henri Mondor

Créteil, , France

Site Status RECRUITING

CHU Francois MITTERRAND

Dijon, , France

Site Status RECRUITING

Service Hématologie, Centre Hospitalier de Dunkerque

Dunkirk, , France

Site Status RECRUITING

Service Oncologie médicale, Groupe Hospitalier Mutualiste de Grenoble, Institut Daniel Hollard,

Grenoble, , France

Site Status RECRUITING

CHD Vendée

La Roche-sur-Yon, , France

Site Status RECRUITING

Service d'Hématologie Clinique, Centre Hospitalier Universitaire Michallon

La Tronche, , France

Site Status RECRUITING

Clinique Victor Hugo

Le Mans, , France

Site Status RECRUITING

Centre hospitalier Libourne

Libourne, , France

Site Status RECRUITING

Service Oncologie médicale, HOPITAL SAINT VINCENT-DE-PAUL

Lille, , France

Site Status RECRUITING

Service des maladies du sang, Hôpital Claude Huriez, CHRU de Lille

Lille, , France

Site Status RECRUITING

Service Hématologie Clinique et Thérapie Cellulaire, CHU DE LIMOGES - HOPITAL DUPUYTREN,

Limoges, , France

Site Status RECRUITING

Département d'Hématologie et Oncologie, Centre Léon Bérard

Lyon, , France

Site Status RECRUITING

Département d'Hématologie Clinique, Hôpital Saint-Eloi,

Montpellier, , France

Site Status RECRUITING

Service Hématologie, GH REGION MULHOUSE ET SUD ALSACE - HOPITAL EMILE MULLER,

Mulhouse, , France

Site Status RECRUITING

Service d'Hématologie clinique, Centre Hospitalier Universitaire de Nantes

Nantes, , France

Site Status RECRUITING

Centre Hospitalier de Niort

Niort, , France

Site Status RECRUITING

Service Hématologie, Hôpital St Louis

Paris, , France

Site Status RECRUITING

CHU Haut-Lévêque

Pessac, , France

Site Status RECRUITING

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status RECRUITING

Service d'Hématologie et Thérapie Cellulaire, Centre Hospitalier Universitaire de Poitiers

Poitiers, , France

Site Status RECRUITING

Hématologie Clinique, CHU PONTCHAILLOU

Rennes, , France

Site Status RECRUITING

Service Hématologie, Centre Hospitalier de Roubaix - Hôpital Victor Provo

Roubaix, , France

Site Status RECRUITING

Service Hématologie, UNIVERSITE DE ROUEN, CENTRE HENRI BECQUEREL

Rouen, , France

Site Status RECRUITING

Service Hématologie, CH YVES LE FOLL

Saint-Brieuc, , France

Site Status RECRUITING

Service Hématologie, Institut Curie - Hôpital René HUGUENIN

Saint-Cloud, , France

Site Status RECRUITING

Département d'Hématologie Clinique et Thérapie Cellulaire, Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, , France

Site Status RECRUITING

Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status RECRUITING

Institut Universitaire du Cancer

Toulouse, , France

Site Status RECRUITING

Hématologie Clinique, CH DE BRETAGNE ATLANTIQUE

Vannes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Hervé Ghesquières, MD

Role: CONTACT

04 78 86 43 40 ext. +33

Alain Monnereau, MD

Role: CONTACT

05 56 33 33 33 ext. +33

Facility Contacts

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Pauline LIONNE-HUYGHE, MD

Role: primary

+33 (0)3 21 21 10 10

Adrien CHAUCHET, MD

Role: primary

+33 (0)3 81 66 82 32

Olivier FITOUSSI, MD

Role: primary

+33 (0) 5 56 43 73 54

Fontanet BIJOU, MD

Role: primary

05 56 33 33 39 ext. +33

Florence LACHENAL, MD

Role: primary

+33 (0)4 69 15 73 29

Gandhi DAMAJ, PhD

Role: primary

+33 (0) 2 31 27 25 36

Gian Matteo PICA, MD

Role: primary

0)4 79 96 50 50

Romain GUIEZE, PhD

Role: primary

Corinne HAIOUN, PhD

Role: primary

+33 (0) 1 49 81 20 51

René-Olivier CASASNOVAS, MD

Role: primary

03 80 29 50 41

Cédric ROSSI, MD

Role: backup

03 80 29 50 41 ext. +33

Christophe FRUCHART, MD

Role: primary

+33 (0)3 28 28 55 29

Cécile LEYRONNAS, MD

Role: primary

+33 (0)4 76 28 52 32

Nadine MORINEAU, MD

Role: primary

02 51 44 61 73 ext. +33

Rémy GRESSIN, MD

Role: primary

+33 (0) 4 76 76 57 12

Katell LE DÛ, MD

Role: primary

+33 (0)2 43 47 94 93

Gaelle LABOURE, MD

Role: primary

+33557553340

Sandy AMORIM, MD

Role: primary

+33 (0)3 20 87 45 32

Franck MORSCHHAUSER, MD

Role: primary

+33 (0) 3 20 44 60 68

Julie ABRAHAM, MD

Role: primary

+33 (0)5 55 05 66 51

Laure LEBRAS, MD

Role: primary

+33 (0) 4 78 78 27 37

Guillaume CARTRON, PhD

Role: primary

+33 (0) 4 67 33 67 33

Bernard DRENOU, MD

Role: primary

+33 (0)3 89 64 75 21

Thomas GASTINNE, PhD

Role: primary

+33 (0) 2 40 08 32 71

Gaëlle Olivier, MD

Role: primary

+33 (0)5 49 78 35 61

Catherine THIEBLEMONT, PhD

Role: primary

+33 (0) 1 42 49 98 37

Kamal-Krimo BOUABDALLAH, MD

Role: primary

05 57 65 65 11 ext. +33

Hervé Ghesquières, MD

Role: primary

04 78 86 43 40 ext. +33

Alain Monnereau

Role: backup

05 56 33 33 33 ext. +33

Stéphanie GUIDEZ, MD

Role: primary

+33 (0) 5 49 44 44 44

Thierry LAMY DE LA CHAPELLE, PhD

Role: primary

+33 (0)2 99 28 42 91

Laurence DETOURMIGNIES, MD

Role: primary

+33 (0)3 20 99 32 70

Fabrice JARDIN, PhD

Role: primary

+33 (0)2 32 08 24 65

Vincent LAUNAY, MD

Role: primary

+33 (0)2 96 01 70 82

Carole SOUSSAIN, MD

Role: primary

+33 (0)1 47 11 15 15

Ludovic FOUILLET, MD

Role: primary

+33 (0)4 77 91 70 60

Luc-Matthieu FORNECKER, MD

Role: primary

03 88 12 76 79 ext. +33

Loïc YSEBAERT, MD

Role: primary

05 31 15 63 51 ext. +33

Antoine BONNET, MD

Role: primary

+33 (0)2 97 01 46 35

References

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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.

Reference Type DERIVED
PMID: 37874913 (View on PubMed)

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 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.

Reference Type DERIVED
PMID: 33653294 (View on PubMed)

Other Identifiers

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2018-A01332-53

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL18_0352

Identifier Type: -

Identifier Source: org_study_id

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