REal World Data in LYmphoma and Survival in Adults (REALYSA)

REAL WORLD DATA IN LYMPHOMA AND SURVIVAL IN ADULTS

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

Study Overview

• Status: Recruiting
• Conditions: Mantle Cell Lymphoma (MCL); Follicular Lymphoma (FL); Diffuse Large B Lymphoma (DLBCL); Marginal Zone Lymphoma (MZL); T-cell Lymphoma (T-NHL); Hodgkin's Lymphoma (HL); Burkitt Lymphoma (BL))
• Intervention / Treatment: Other: Real-life epidemiological platform of lymphoma in France

• Study Type: Observational
• Enrollment (Anticipated): 6000

Contacts and Locations

• Study Contact: Name: Hervé Ghesquières, MD; Phone Number: +33 04 78 86 43 40; Email: herve.ghesquieres@chu-lyon.fr
• Study Contact Backup: Name: Alain Monnereau, MD; Phone Number: +33 05 56 33 33 33; Email: A.Monnereau@bordeaux.unicancer.fr

Study Locations

• France
  • Arras, France, 62022
    • Recruiting
    • Unité d'Hématologie Clinique, CH D'ARRAS
    • Contact: Pauline LIONNE-HUYGHE, MD; Phone Number: +33 (0)3 21 21 10 10; Email: pauline.lionne-huyghe@ch-arras.fr
  • Besançon, France, 25030
    • Recruiting
    • Service d'Hématologie, CHU Jean Minjoz
    • Contact: Adrien CHAUCHET, MD; Phone Number: +33 (0)3 81 66 82 32; Email: achauchet@chu-besancon.fr
  • Bordeaux, France
    • Recruiting
    • Institut Bergonié
    • Principal Investigator: Fontanet Bijou, MD
    • Contact: Fontanet BIJOU, MD; Phone Number: +33 05 56 33 33 39; Email: f.bijou@bordeaux.unicancer.fr
  • Bordeaux, France, 33300
    • Recruiting
    • Service d'Onco-radiolothérapie, Polyclinique Bordeaux Nord Aquitaine
    • Contact: Olivier FITOUSSI, MD; Phone Number: +33 (0) 5 56 43 73 54; Email: o.fitoussi@bordeauxnord.com
  • Bourgoin-Jallieu, France, 38302
    • Recruiting
    • Centre hospitalier Pierre Oudot
    • Contact: Florence LACHENAL, MD; Phone Number: +33 (0)4 69 15 73 29; Email: flachenal@ch-bourgoin.fr
  • Caen, France, 14000
    • Recruiting
    • Service d'Hématologie, Institut d'Hématologie de Basse Normandie
    • Contact: Gandhi DAMAJ, PhD; Phone Number: +33 (0) 2 31 27 25 36; Email: damaj-gl@chu-caen.fr
  • Chambéry, France, 73000
    • Recruiting
    • METROPOLE SAVOIE - SITE CHAMBERY, place Lucien Biset,
    • Contact: Gian Matteo PICA, MD; Phone Number: 0)4 79 96 50 50; Email: gian-matteo.pica@ch-metropole-savoie.fr
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • Service d'Hématologie Clinique et de Thérapie Cellulaire, Hôpital Estaing, CHU de Clermont-Ferrand
    • Contact: Romain GUIEZE, PhD
  • Créteil, France, 94010
    • Recruiting
    • Unité Hémopathies Lymphoïdes, Hôpital Henri Mondor
    • Contact: Corinne HAIOUN, PhD; Phone Number: +33 (0) 1 49 81 20 51; Email: corinne.haioun@aphp.fr
  • Dijon, France
    • Recruiting
    • CHU Francois Mitterrand
    • Contact: René-Olivier CASASNOVAS, MD; Phone Number: 03 80 29 50 41; Email: olivier.casasnovas@chu-dijon.fr
    • Contact: Cédric ROSSI, MD; Phone Number: +33 03 80 29 50 41; Email: cedric.rossi@chu-dijon.fr
    • Principal Investigator: Cédric ROSSI, MD
  • Dunkerque, France, 59140
    • Recruiting
    • Service Hématologie, Centre Hospitalier de Dunkerque
    • Contact: Christophe FRUCHART, MD; Phone Number: +33 (0)3 28 28 55 29; Email: christophe.fruchart@ch-dunkerque.fr
  • Grenoble, France, 38028
    • Recruiting
    • Service Oncologie médicale, Groupe Hospitalier Mutualiste de Grenoble, Institut Daniel Hollard,
    • Contact: Cécile LEYRONNAS, MD; Phone Number: +33 (0)4 76 28 52 32; Email: c.leyronnas@ghm-grenoble.fr
  • La Roche-sur-Yon, France
    • Recruiting
    • CHD Vendee
    • Contact: Nadine MORINEAU, MD; Phone Number: +33 02 51 44 61 73; Email: nadine.morineau@chd-vendee.fr
    • Principal Investigator: Nadine Morineau, MD
  • La Tronche, France, 38700
    • Recruiting
    • Service d'Hématologie Clinique, Centre Hospitalier Universitaire Michallon
    • Contact: Rémy GRESSIN, MD; Phone Number: +33 (0) 4 76 76 57 12; Email: rgressin@chu-grenoble.fr
  • Le Mans, France, 72000
    • Recruiting
    • Clinique Victor Hugo
    • Contact: Katell LE DÛ, MD; Phone Number: +33 (0)2 43 47 94 93; Email: k.ledu@cjb72.org
  • Libourne, France, 33500
    • Recruiting
    • Centre hospitalier Libourne
    • Contact: Gaelle LABOURE, MD; Phone Number: +33557553340; Email: gaelle.laboure@ch-libourne.fr
  • Lille, France, 59020
    • Recruiting
    • Service Oncologie médicale, HOPITAL SAINT VINCENT-DE-PAUL
    • Contact: Sandy AMORIM, MD; Phone Number: +33 (0)3 20 87 45 32; Email: amorim.sandy@ghicl.net
  • Lille, France, 59037
    • Recruiting
    • Service des maladies du sang, Hôpital Claude Huriez, CHRU de Lille
    • Contact: Franck MORSCHHAUSER, MD; Phone Number: +33 (0) 3 20 44 60 68; Email: franck.morschhauser@chru-lille.fr
  • Limoges, France, 87042
    • Recruiting
    • Service Hématologie Clinique et Thérapie Cellulaire, CHU DE LIMOGES - HOPITAL DUPUYTREN,
    • Contact: Julie ABRAHAM, MD; Phone Number: +33 (0)5 55 05 66 51; Email: julie.abraham@chu-limoges.fr
  • Lyon, France, 69008
    • Recruiting
    • Département d'Hématologie et Oncologie, Centre Léon Bérard
    • Contact: Laure LEBRAS, MD; Phone Number: +33 (0) 4 78 78 27 37; Email: laure.lebras@lyon.unicancer.fr
  • Montpellier, France, 34295
    • Recruiting
    • Département d'Hématologie Clinique, Hôpital Saint-Eloi,
    • Contact: Guillaume CARTRON, PhD; Phone Number: +33 (0) 4 67 33 67 33; Email: g-cartron@chu-montpellier.fr
  • Mulhouse, France, 68070
    • Recruiting
    • Service Hématologie, GH REGION MULHOUSE ET SUD ALSACE - HOPITAL EMILE MULLER,
    • Contact: Bernard Drenou, MD; Phone Number: +33 (0)3 89 64 75 21; Email: drenoub@ghrmsa.fr
  • Nantes, France, 44093
    • Recruiting
    • Service d'Hématologie clinique, Centre Hospitalier Universitaire de Nantes
    • Contact: Thomas GASTINNE, PhD; Phone Number: +33 (0) 2 40 08 32 71; Email: thomas.gastinne@chu-nantes.fr
  • Niort, France, 79021
    • Recruiting
    • Centre Hospitalier de Niort
    • Contact: Gaëlle Olivier, MD; Phone Number: +33 (0)5 49 78 35 61; Email: gaelle.olivier@ch-niort.fr
  • Paris, France, 75475
    • Recruiting
    • Service Hématologie, Hôpital St Louis
    • Contact: Catherine THIEBLEMONT, PhD; Phone Number: +33 (0) 1 42 49 98 37; Email: catherine.thieblemont@aphp.fr
  • Pessac, France
    • Recruiting
    • CHU Haut-Leveque
    • Contact: Kamal-Krimo BOUABDALLAH, MD; Phone Number: +33 05 57 65 65 11; Email: krimo.bouabdallah@chu-bordeaux.fr
    • Principal Investigator: Kamal-Krimo BOUABDALLAH, MD
  • Pierre-Bénite, France
    • Recruiting
    • Centre Hospitalier Lyon Sud
    • Contact: Hervé Ghesquières, MD; Phone Number: +33 04 78 86 43 40; Email: herve.ghesquieres@chu-lyon.fr
    • Contact: Alain Monnereau; Phone Number: +33 05 56 33 33 33; Email: A.Monnereau@bordeaux.unicancer.fr
  • Poitiers, France, 86021
    • Recruiting
    • Service d'Hématologie et Thérapie Cellulaire, Centre Hospitalier Universitaire de Poitiers
    • Contact: Stéphanie GUIDEZ, MD; Phone Number: +33 (0) 5 49 44 44 44; Email: Stephanie.guidez@chu-poitiers.fr
  • Rennes, France, 35033
    • Recruiting
    • Hématologie Clinique, CHU PONTCHAILLOU
    • Contact: Thierry LAMY DE LA CHAPELLE, PhD; Phone Number: +33 (0)2 99 28 42 91; Email: thierry.lamy.de.la.chapelle@chu-rennes.fr
  • Roubaix, France, 59056
    • Recruiting
    • Service Hématologie, Centre Hospitalier de Roubaix - Hôpital Victor Provo
    • Contact: Laurence DETOURMIGNIES, MD; Phone Number: +33 (0)3 20 99 32 70; Email: isabelle.plantier@ch-roubaix.fr
  • Rouen, France, 76038
    • Recruiting
    • Service Hématologie, UNIVERSITE DE ROUEN, CENTRE HENRI BECQUEREL
    • Contact: Fabrice JARDIN, PhD; Phone Number: +33 (0)2 32 08 24 65; Email: fabrice.jardin@chb.unicancer.fr
  • Saint-Brieuc, France, 22027
    • Recruiting
    • Service Hématologie, CH YVES LE FOLL
    • Contact: Vincent LAUNAY, MD; Phone Number: +33 (0)2 96 01 70 82; Email: vincent.launay@ch-stbrieuc.fr
  • Saint-Cloud, France, 92210
    • Recruiting
    • Service Hématologie, Institut Curie - Hôpital René HUGUENIN
    • Contact: Carole SOUSSAIN, MD; Phone Number: +33 (0)1 47 11 15 15; Email: carole.soussain@curie.fr
  • Saint-Priest-en-Jarez, France, 42270
    • Recruiting
    • Département d'Hématologie Clinique et Thérapie Cellulaire, Institut de Cancérologie Lucien Neuwirth
    • Contact: Ludovic FOUILLET, MD; Phone Number: +33 (0)4 77 91 70 60; Email: ludovic.fouillet@icloire.fr
  • Strasbourg, France
    • Recruiting
    • Hopitaux Universitaires de Strasbourg
    • Principal Investigator: Luc-Matthieu FORNECKER, MD
    • Contact: Luc-Matthieu FORNECKER, MD; Phone Number: +33 03 88 12 76 79; Email: luc-matthieu.fornecker@chru-strasbourg.fr
  • Toulouse, France
    • Recruiting
    • Institut universitaire du cancer
    • Principal Investigator: Loïc Ysebaert, MD
    • Contact: Loïc YSEBAERT, MD; Phone Number: +33 05 31 15 63 51; Email: ysebaert.loic@iuct-oncopole.fr
  • Vannes, France, 56017
    • Recruiting
    • Hématologie Clinique, CH DE BRETAGNE ATLANTIQUE
    • Contact: Antoine BONNET, MD; Phone Number: +33 (0)2 97 01 46 35; Email: antoine.bonnet@ch-bretagne-atlantique.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with lymphoma in the last 6 months.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-Free Survival (PFS)	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Response rate	5 years
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	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

Outcome Measure	Measure Description	Time Frame
Representativeness of the included population	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).	5 years
Representativeness of the included population	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).	9 years

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Collaborators: The Lymphoma Academic Research Organisation
• Investigators: Study Director: Hervé Ghesquières, MD, Hospices Civils de Lyon; Study Director: Alain Monnereau, MD, Université de Bordeaux : Inserm

Publications and helpful links

General Publications

• Ghesquières 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, Labouré 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2018
• Primary Completion (Anticipated): November 14, 2027
• Study Completion (Anticipated): November 14, 2027

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Actual): June 28, 2021
• Last Update Submitted That Met QC Criteria: June 25, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: lymphoma; epidemiology; PRO; cohort; real life
• Additional Relevant MeSH Terms: Virus Diseases; Infections; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; DNA Virus Infections; Tumor Virus Infections; Epstein-Barr Virus Infections; Herpesviridae Infections; Lymphoma, B-Cell; Lymphoma; Burkitt Lymphoma; Lymphoma, Mantle-Cell
• Other Study ID Numbers: 69HCL18_0352; 2018-A01332-53 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No