REALYSA: REal World Data in LYmphoma and Survival in Adults

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT03869619

Collaborator

The Lymphoma Academic Research Organisation (Other)

6,000

Enrollment

Locations

108

Anticipated Duration (Months)

162.2

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
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))	Other: Real-life epidemiological platform of lymphoma in France

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

6000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

REAL WORLD DATA IN LYMPHOMA AND SURVIVAL IN ADULTS

Actual Study Start Date :

Nov 14, 2018

Anticipated Primary Completion Date :

Nov 14, 2027

Anticipated Study Completion Date :

Nov 14, 2027

Arms and Interventions

Arm	Intervention/Treatment
All enrolled patients All patient who signed the consent form for participation to the study	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

Arm

Intervention/Treatment

All enrolled patients

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

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

Outcome Measures

Primary Outcome Measures

Progression-Free Survival (PFS) [5 years]

Secondary Outcome Measures

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]

Other Outcome Measures

Representativeness of the included population [5 years]
Study population must show a good representativeness of the source population regarding demographic or diseases characteristics, to be able to generalize our results. Indeed, the representativeness of the study population can only be evaluated in areas covered by population-based cancer registries (PBCR) by comparing cases included in the REALYSA project to incident lymphoma cases registered in the general population (PBCR of the FRANCIM network).
Representativeness of the included population [9 years]
Study population must show a good representativeness of the source population regarding demographic or diseases characteristics, to be able to generalize our results. Indeed, the representativeness of the study population can only be evaluated in areas covered by population-based cancer registries (PBCR) by comparing cases included in the REALYSA project to incident lymphoma cases registered in the general population (PBCR of the FRANCIM network).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Unité d'Hématologie Clinique, CH D'ARRAS	Arras	France	62022
2	Service d'Hématologie, CHU Jean Minjoz	Besançon	France	25030
3	Service d'Onco-radiolothérapie, Polyclinique Bordeaux Nord Aquitaine	Bordeaux	France	33300
4	Institut Bergonié	Bordeaux	France
5	Centre Hospitalier Pierre Oudot	Bourgoin-Jallieu	France	38302
6	Service d'Hématologie, Institut d'Hématologie de Basse Normandie	Caen	France	14000
7	METROPOLE SAVOIE - SITE CHAMBERY, place Lucien Biset,	Chambéry	France	73000
8	Service d'Hématologie Clinique et de Thérapie Cellulaire, Hôpital Estaing, CHU de Clermont-Ferrand	Clermont-Ferrand	France	63000
9	Unité Hémopathies Lymphoïdes, Hôpital Henri Mondor	Créteil	France	94010
10	CHU Francois MITTERRAND	Dijon	France
11	Service Hématologie, Centre Hospitalier de Dunkerque	Dunkerque	France	59140
12	Service Oncologie médicale, Groupe Hospitalier Mutualiste de Grenoble, Institut Daniel Hollard,	Grenoble	France	38028
13	CHD Vendée	La Roche-sur-Yon	France
14	Service d'Hématologie Clinique, Centre Hospitalier Universitaire Michallon	La Tronche	France	38700
15	Clinique Victor Hugo	Le Mans	France	72000
16	Centre hospitalier Libourne	Libourne	France	33500
17	Service Oncologie médicale, HOPITAL SAINT VINCENT-DE-PAUL	Lille	France	59020
18	Service des maladies du sang, Hôpital Claude Huriez, CHRU de Lille	Lille	France	59037
19	Service Hématologie Clinique et Thérapie Cellulaire, CHU DE LIMOGES - HOPITAL DUPUYTREN,	Limoges	France	87042
20	Département d'Hématologie et Oncologie, Centre Léon Bérard	Lyon	France	69008
21	Département d'Hématologie Clinique, Hôpital Saint-Eloi,	Montpellier	France	34295
22	Service Hématologie, GH REGION MULHOUSE ET SUD ALSACE - HOPITAL EMILE MULLER,	Mulhouse	France	68070
23	Service d'Hématologie clinique, Centre Hospitalier Universitaire de Nantes	Nantes	France	44093
24	Centre Hospitalier de Niort	Niort	France	79021
25	Service Hématologie, Hôpital St Louis	Paris	France	75475
26	CHU Haut-Lévêque	Pessac	France
27	Centre Hospitalier Lyon Sud	Pierre-Bénite	France
28	Service d'Hématologie et Thérapie Cellulaire, Centre Hospitalier Universitaire de Poitiers	Poitiers	France	86021
29	Hématologie Clinique, CHU PONTCHAILLOU	Rennes	France	35033
30	Service Hématologie, Centre Hospitalier de Roubaix - Hôpital Victor Provo	Roubaix	France	59056
31	Service Hématologie, UNIVERSITE DE ROUEN, CENTRE HENRI BECQUEREL	Rouen	France	76038
32	Service Hématologie, CH YVES LE FOLL	Saint-Brieuc	France	22027
33	Service Hématologie, Institut Curie - Hôpital René HUGUENIN	Saint-Cloud	France	92210
34	Département d'Hématologie Clinique et Thérapie Cellulaire, Institut de Cancérologie Lucien Neuwirth	Saint-Priest-en-Jarez	France	42270
35	Hôpitaux Universitaires de Strasbourg	Strasbourg	France
36	Institut Universitaire du Cancer	Toulouse	France
37	Hématologie Clinique, CH DE BRETAGNE ATLANTIQUE	Vannes	France	56017