Diffuse Large B Lymphoma (DLBCL)REALYSANCT03869619
REal World Data in LYmphoma and Survival in Adults
An observational study of Diffuse Large B Lymphoma (DLBCL) and Follicular Lymphoma (FL), run by Hospices Civils de Lyon at 37 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL)
- What is being tested?
- Real-life epidemiological platform of lymphoma in France
- How many people
- 6,000 participants
- Where
- 37 sitesFrance
- Study dates
- 14 Nov 2018to 14 Nov 2027
- How long will I take part?
- 9 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with lymphoma in the last 6 months.
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
37 sites in 1 country. Contact the study team or a site near you to ask about taking part.
37 sites in 1 country
France37 sites, 37 recruiting
- Recruiting
Unité d'Hématologie Clinique, CH D'ARRAS
Arras, 62022
Pauline LIONNE-HUYGHE, MD, +33 (0)3 21 21 10 10, pauline.lionne-huyghe@ch-arras.fr
- Recruiting
Service d'Hématologie, CHU Jean Minjoz
Besançon, 25030
Adrien CHAUCHET, MD, +33 (0)3 81 66 82 32, achauchet@chu-besancon.fr
- Recruiting
Service d'Onco-radiolothérapie, Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300
Olivier FITOUSSI, MD, +33 (0) 5 56 43 73 54, o.fitoussi@bordeauxnord.com
- Recruiting
Institut Bergonié
Bordeaux
Fontanet BIJOU, MD, 05 56 33 33 39 ext. +33, f.bijou@bordeaux.unicancer.fr
Fontanet BIJOU, MD
- Recruiting
Centre Hospitalier Pierre Oudot
Bourgoin, 38302
Florence LACHENAL, MD, +33 (0)4 69 15 73 29, flachenal@ch-bourgoin.fr
- Recruiting
Service d'Hématologie, Institut d'Hématologie de Basse Normandie
Caen, 14000
Gandhi DAMAJ, PhD, +33 (0) 2 31 27 25 36, damaj-gl@chu-caen.fr
- Recruiting
METROPOLE SAVOIE - SITE CHAMBERY, place Lucien Biset,
Chambéry, 73000
Gian Matteo PICA, MD, 0)4 79 96 50 50, gian-matteo.pica@ch-metropole-savoie.fr
- Recruiting
Service d'Hématologie Clinique et de Thérapie Cellulaire, Hôpital Estaing, CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Romain GUIEZE, PhD
- Recruiting
Unité Hémopathies Lymphoïdes, Hôpital Henri Mondor
Créteil, 94010
Corinne HAIOUN, PhD, +33 (0) 1 49 81 20 51, corinne.haioun@aphp.fr
- Recruiting
CHU Francois MITTERRAND
Dijon
René-Olivier CASASNOVAS, MD, 03 80 29 50 41, olivier.casasnovas@chu-dijon.fr
Cédric ROSSI, MD, 03 80 29 50 41 ext. +33, cedric.rossi@chu-dijon.fr
- Recruiting
Service Hématologie, Centre Hospitalier de Dunkerque
Dunkirk, 59140
Christophe FRUCHART, MD, +33 (0)3 28 28 55 29, christophe.fruchart@ch-dunkerque.fr
- Recruiting
Service Oncologie médicale, Groupe Hospitalier Mutualiste de Grenoble, Institut Daniel Hollard,
Grenoble, 38028
Cécile LEYRONNAS, MD, +33 (0)4 76 28 52 32, c.leyronnas@ghm-grenoble.fr
- Recruiting
CHD Vendée
La Roche-sur-Yon
Nadine MORINEAU, MD, 02 51 44 61 73 ext. +33, nadine.morineau@chd-vendee.fr
Nadine MORINEAU, MD
- Recruiting
Service d'Hématologie Clinique, Centre Hospitalier Universitaire Michallon
La Tronche, 38700
Rémy GRESSIN, MD, +33 (0) 4 76 76 57 12, rgressin@chu-grenoble.fr
- Recruiting
Clinique Victor Hugo
Le Mans, 72000
Katell LE DÛ, MD, +33 (0)2 43 47 94 93, k.ledu@cjb72.org
- Recruiting
Centre hospitalier Libourne
Libourne, 33500
Gaelle LABOURE, MD, +33557553340, gaelle.laboure@ch-libourne.fr
- Recruiting
Service Oncologie médicale, HOPITAL SAINT VINCENT-DE-PAUL
Lille, 59020
Sandy AMORIM, MD, +33 (0)3 20 87 45 32, amorim.sandy@ghicl.net
- Recruiting
Service des maladies du sang, Hôpital Claude Huriez, CHRU de Lille
Lille, 59037
Franck MORSCHHAUSER, MD, +33 (0) 3 20 44 60 68, franck.morschhauser@chru-lille.fr
- Recruiting
Service Hématologie Clinique et Thérapie Cellulaire, CHU DE LIMOGES - HOPITAL DUPUYTREN,
Limoges, 87042
Julie ABRAHAM, MD, +33 (0)5 55 05 66 51, julie.abraham@chu-limoges.fr
- Recruiting
Département d'Hématologie et Oncologie, Centre Léon Bérard
Lyon, 69008
Laure LEBRAS, MD, +33 (0) 4 78 78 27 37, laure.lebras@lyon.unicancer.fr
- Recruiting
Département d'Hématologie Clinique, Hôpital Saint-Eloi,
Montpellier, 34295
Guillaume CARTRON, PhD, +33 (0) 4 67 33 67 33, g-cartron@chu-montpellier.fr
- Recruiting
Service Hématologie, GH REGION MULHOUSE ET SUD ALSACE - HOPITAL EMILE MULLER,
Mulhouse, 68070
Bernard DRENOU, MD, +33 (0)3 89 64 75 21, drenoub@ghrmsa.fr
- Recruiting
Service d'Hématologie clinique, Centre Hospitalier Universitaire de Nantes
Nantes, 44093
Thomas GASTINNE, PhD, +33 (0) 2 40 08 32 71, thomas.gastinne@chu-nantes.fr
- Recruiting
Centre Hospitalier de Niort
Niort, 79021
Gaëlle Olivier, MD, +33 (0)5 49 78 35 61, gaelle.olivier@ch-niort.fr
- Recruiting
Service Hématologie, Hôpital St Louis
Paris, 75475
Catherine THIEBLEMONT, PhD, +33 (0) 1 42 49 98 37, catherine.thieblemont@aphp.fr
- Recruiting
CHU Haut-Lévêque
Pessac
Kamal-Krimo BOUABDALLAH, MD, 05 57 65 65 11 ext. +33, krimo.bouabdallah@chu-bordeaux.fr
Kamal-Krimo BOUABDALLAH, MD
- Recruiting
Centre Hospitalier Lyon Sud
Pierre-Bénite
Hervé Ghesquières, MD, 04 78 86 43 40 ext. +33, herve.ghesquieres@chu-lyon.fr
Alain Monnereau, 05 56 33 33 33 ext. +33, A.Monnereau@bordeaux.unicancer.fr
- Recruiting
Service d'Hématologie et Thérapie Cellulaire, Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021
Stéphanie GUIDEZ, MD, +33 (0) 5 49 44 44 44, Stephanie.guidez@chu-poitiers.fr
- Recruiting
Hématologie Clinique, CHU PONTCHAILLOU
Rennes, 35033
Thierry LAMY DE LA CHAPELLE, PhD, +33 (0)2 99 28 42 91, thierry.lamy.de.la.chapelle@chu-rennes.fr
- Recruiting
Service Hématologie, Centre Hospitalier de Roubaix - Hôpital Victor Provo
Roubaix, 59056
Laurence DETOURMIGNIES, MD, +33 (0)3 20 99 32 70, isabelle.plantier@ch-roubaix.fr
- Recruiting
Service Hématologie, UNIVERSITE DE ROUEN, CENTRE HENRI BECQUEREL
Rouen, 76038
Fabrice JARDIN, PhD, +33 (0)2 32 08 24 65, fabrice.jardin@chb.unicancer.fr
- Recruiting
Service Hématologie, CH YVES LE FOLL
Saint-Brieuc, 22027
Vincent LAUNAY, MD, +33 (0)2 96 01 70 82, vincent.launay@ch-stbrieuc.fr
- Recruiting
Service Hématologie, Institut Curie - Hôpital René HUGUENIN
Saint-Cloud, 92210
Carole SOUSSAIN, MD, +33 (0)1 47 11 15 15, carole.soussain@curie.fr
- Recruiting
Département d'Hématologie Clinique et Thérapie Cellulaire, Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42270
Ludovic FOUILLET, MD, +33 (0)4 77 91 70 60, ludovic.fouillet@icloire.fr
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg
Luc-Matthieu FORNECKER, MD, 03 88 12 76 79 ext. +33, luc-matthieu.fornecker@chru-strasbourg.fr
Luc-Matthieu FORNECKER, MD
- Recruiting
Institut Universitaire du Cancer
Toulouse
Loïc YSEBAERT, MD, 05 31 15 63 51 ext. +33, ysebaert.loic@iuct-oncopole.fr
Loïc YSEBAERT, MD
- Recruiting
Hématologie Clinique, CH DE BRETAGNE ATLANTIQUE
Vannes, 56017
Antoine BONNET, MD, +33 (0)2 97 01 46 35, antoine.bonnet@ch-bretagne-atlantique.fr
About this study
Official title: 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
- 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)
- Being tested
- Real-life epidemiological platform of lymphoma in France
- Keywords
- lymphoma, real life, cohort, epidemiology, PRO
- Medical subject headings
- Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone, Lymphoma, T-Cell, Hodgkin Disease, Burkitt Lymphoma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-life epidemiological platform of lymphoma in FranceOther
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
| Study group | Role | What they receive |
|---|---|---|
| All enrolled patients | All patient who signed the consent form for participation to the study Receives: Other: Real-life epidemiological platform of lymphoma in France |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Measured: 5 years
Secondary outcomes (25)
Number of patients included per month in total and according to subtype of lymphoma
Measured: 5 years
Number of patients in each region in total and according to subtype of lymphoma
Measured: 9 years
Progression-Free Survival (PFS)
Measured: 9 years
Event-Free Survival (EFS)
Measured: 5 years
Event-Free Survival (EFS)
Measured: 9 years
Overall Survival (OS)
Measured: 5 years
Overall Survival (OS)
Measured: 9 years
Net Survival
Measured: 5 years
Net Survival
Measured: 9 years
Response rate
Measured: 5 years
Response rate
Measured: 9 years
Duration of response
Measured: 5 years
Duration of response
Measured: 9 years
Time to Next Anti-Lymphoma Treatment (TTNLT)
Measured: 5 years
Time to Next Anti-Lymphoma Treatment (TTNLT)
Measured: 9 years
Duration of Survival after progression
Measured: 5 years
Duration of Survival after progression
Measured: 9 years
Frequency of Lymphoma transformations
Measured: 5 years
Frequency of Lymphoma transformations
Measured: 9 years
Frequency of Second cancers
Measured: 5 years
Frequency of Second cancers
Measured: 9 years
Frequency of other chronic disease
Measured: 5 years
Frequency of other chronic disease
Measured: 9 years
Number of exposure factors
Measured: Baseline
Number of comorbidities
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start14 Nov 2018
- Primary completion14 Nov 2027 (estimated)
- Study completion14 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diffuse Large B Lymphoma (DLBCL)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
- Target duration
- 9 Years
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- The Lymphoma Academic Research Organisation
- Responsible party
- Sponsor
- Investigators
- Hervé Ghesquières, MD, Study director, Hospices Civils de LyonAlain Monnereau, MD, Study director, Université de Bordeaux : Inserm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869619
- Sponsor's protocol ID
- 69HCL18_0352
- Other IDs
- 2018-A01332-53
- Acronym
- REALYSA
- Status last verified
- Jun 2021
- First submitted
- 16 Aug 2018
- Last updated
- 28 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37874913Ghesquieres 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.
PubMed 33653294
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REAL WORLD DATA IN LYMPHOMA AND SURVIVAL IN ADULTS
- ClinicalTrials.gov ID
- NCT03869619
- Acronym / sponsor ID
- REALYSA / 69HCL18_0352
- 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)
- Keywords
- lymphoma, real life, cohort, epidemiology, PRO
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- The Lymphoma Academic Research Organisation
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 14 Nov 2027 (estimated)
- Study completion
- 14 Nov 2027 (estimated)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All enrolled patients | – | Other: Real-life epidemiological platform of lymphoma in FranceAll patient who signed the consent form for participation to the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with lymphoma in the last 6 months.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-life epidemiological platform of lymphoma in FranceThe 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 | Other | All enrolled patients |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 5 years
25 secondary outcomes
Number of patients included per month in total and according to subtype of lymphoma
Time frame: 5 years
Number of patients in each region in total and according to subtype of lymphoma
Time frame: 9 years
Progression-Free Survival (PFS)
Time frame: 9 years
Event-Free Survival (EFS)
Time frame: 5 years
Event-Free Survival (EFS)
Time frame: 9 years
Overall Survival (OS)
Time frame: 5 years
Overall Survival (OS)
Time frame: 9 years
Net Survival
Time frame: 5 years
Net Survival
Time frame: 9 years
Response rate
Time frame: 5 years
Response rate
Time frame: 9 years
Duration of response
Time frame: 5 years
Duration of response
Time frame: 9 years
Time to Next Anti-Lymphoma Treatment (TTNLT)
Time frame: 5 years
Time to Next Anti-Lymphoma Treatment (TTNLT)
Time frame: 9 years
Duration of Survival after progression
Time frame: 5 years
Duration of Survival after progression
Time frame: 9 years
Frequency of Lymphoma transformations
Time frame: 5 years
Frequency of Lymphoma transformations
Time frame: 9 years
Frequency of Second cancers
Time frame: 5 years
Frequency of Second cancers
Time frame: 9 years
Frequency of other chronic disease
Time frame: 5 years
Frequency of other chronic disease
Time frame: 9 years
Number of exposure factors
Time frame: Baseline
Number of comorbidities
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Derived from this study: PubMed 37874913Ghesquieres 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.
- Derived from this study: PubMed 33653294Ghesquieres 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hervé Ghesquières, MD study director
Hospices Civils de Lyon
Alain Monnereau, MD study director
Université de Bordeaux : Inserm
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B Lymphoma (DLBCL) and Follicular Lymphoma (FL), run by Hospices Civils de Lyon at 37 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hervé Ghesquières, MD (04 78 86 43 40 ext. +33, herve.ghesquieres@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03869619, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2021; AzTrials last refreshed its copy on 7 Nov 2026.