Clinical trial NCT03869619: REal World Data in LYmphoma and Survival in Adults
Official title: REAL WORLD DATA IN LYMPHOMA AND SURVIVAL IN ADULTS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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))
Keywords: lymphoma
real life
cohort
epidemiology
PRO
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: The Lymphoma Academic Research Organisation
First posted: 2019-03-11
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with lymphoma in the last 6 months.

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


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)

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 5 years
Secondary outcomes:
measure: Number of patients included per month in total and according to subtype of lymphoma
timeFrame: 5 years
measure: Number of patients in each region in total and according to subtype of lymphoma
timeFrame: 9 years
measure: Progression-Free Survival (PFS)
timeFrame: 9 years
measure: Event-Free Survival (EFS)
timeFrame: 5 years
measure: Event-Free Survival (EFS)
timeFrame: 9 years
measure: Overall Survival (OS)
timeFrame: 5 years
measure: Overall Survival (OS)
timeFrame: 9 years
measure: Net Survival
timeFrame: 5 years
measure: Net Survival
timeFrame: 9 years
measure: Response rate
timeFrame: 5 years
measure: Response rate
timeFrame: 9 years
measure: Duration of response
timeFrame: 5 years
measure: Duration of response
timeFrame: 9 years
measure: Time to Next Anti-Lymphoma Treatment (TTNLT)
timeFrame: 5 years
measure: Time to Next Anti-Lymphoma Treatment (TTNLT)
timeFrame: 9 years
measure: Duration of Survival after progression
timeFrame: 5 years
measure: Duration of Survival after progression
timeFrame: 9 years
measure: Frequency of Lymphoma transformations
timeFrame: 5 years
measure: Frequency of Lymphoma transformations
timeFrame: 9 years
measure: Frequency of Second cancers
timeFrame: 5 years
measure: Frequency of Second cancers
timeFrame: 9 years
measure: Frequency of other chronic disease
timeFrame: 5 years
measure: Frequency of other chronic disease
timeFrame: 9 years
measure: Number of exposure factors
timeFrame: Baseline
measure: Number of comorbidities
timeFrame: Baseline
Other outcomes:
measure: Representativeness of the included population
timeFrame: 5 years
measure: Representativeness of the included population
timeFrame: 9 years
Locations:
city: Arras
country: France
facility: Unité d'Hématologie Clinique, CH D'ARRAS
city: Besançon
country: France
facility: Service d'Hématologie, CHU Jean Minjoz
city: Bordeaux
country: France
facility: Service d'Onco-radiolothérapie, Polyclinique Bordeaux Nord Aquitaine
city: Bordeaux
country: France
facility: Institut Bergonié
city: Bourgoin-Jallieu
country: France
facility: Centre Hospitalier Pierre Oudot
city: Caen
country: France
facility: Service d'Hématologie, Institut d'Hématologie de Basse Normandie
city: Chambéry
country: France
facility: METROPOLE SAVOIE - SITE CHAMBERY, place Lucien Biset,
city: Clermont-Ferrand
country: France
facility: Service d'Hématologie Clinique et de Thérapie Cellulaire, Hôpital Estaing, CHU de Clermont-Ferrand
city: Créteil
country: France
facility: Unité Hémopathies Lymphoïdes, Hôpital Henri Mondor
city: Dijon
country: France
facility: CHU Francois MITTERRAND
city: Dunkerque
country: France
facility: Service Hématologie, Centre Hospitalier de Dunkerque
city: Grenoble
country: France
facility: Service Oncologie médicale, Groupe Hospitalier Mutualiste de Grenoble, Institut Daniel Hollard,
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: La Tronche
country: France
facility: Service d'Hématologie Clinique, Centre Hospitalier Universitaire Michallon
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Libourne
country: France
facility: Centre hospitalier Libourne
city: Lille
country: France
facility: Service Oncologie médicale, HOPITAL SAINT VINCENT-DE-PAUL
city: Lille
country: France
facility: Service des maladies du sang, Hôpital Claude Huriez, CHRU de Lille
city: Limoges
country: France
facility: Service Hématologie Clinique et Thérapie Cellulaire, CHU DE LIMOGES - HOPITAL DUPUYTREN,
city: Lyon
country: France
facility: Département d'Hématologie et Oncologie, Centre Léon Bérard
city: Montpellier
country: France
facility: Département d'Hématologie Clinique, Hôpital Saint-Eloi,
city: Mulhouse
country: France
facility: Service Hématologie, GH REGION MULHOUSE ET SUD ALSACE - HOPITAL EMILE MULLER,
city: Nantes
country: France
facility: Service d'Hématologie clinique, Centre Hospitalier Universitaire de Nantes
city: Niort
country: France
facility: Centre Hospitalier de Niort
city: Paris
country: France
facility: Service Hématologie, Hôpital St Louis
city: Pessac
country: France
facility: CHU Haut-Lévêque
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: Service d'Hématologie et Thérapie Cellulaire, Centre Hospitalier Universitaire de Poitiers
city: Rennes
country: France
facility: Hématologie Clinique, CHU PONTCHAILLOU
city: Roubaix
country: France
facility: Service Hématologie, Centre Hospitalier de Roubaix - Hôpital Victor Provo
city: Rouen
country: France
facility: Service Hématologie, UNIVERSITE DE ROUEN, CENTRE HENRI BECQUEREL
city: Saint-Brieuc
country: France
facility: Service Hématologie, CH YVES LE FOLL
city: Saint-Cloud
country: France
facility: Service Hématologie, Institut Curie - Hôpital René HUGUENIN
city: Saint-Priest-en-Jarez
country: France
facility: Département d'Hématologie Clinique et Thérapie Cellulaire, Institut de Cancérologie Lucien Neuwirth
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
city: Toulouse
country: France
facility: Institut Universitaire du Cancer
city: Vannes
country: France
facility: Hématologie Clinique, CH DE BRETAGNE ATLANTIQUE
Study officials:
affiliation: Hospices Civils de Lyon
name: Hervé Ghesquières, MD
role: STUDY_DIRECTOR
affiliation: Université de Bordeaux : Inserm
name: Alain Monnereau, MD
role: STUDY_DIRECTOR
References:
citation: 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.