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REal World Data in LYmphoma and Survival in Adults

REAL WORLD DATA IN LYMPHOMA AND SURVIVAL IN ADULTS

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03869619
Acronym
REALYSA
Enrollment
6000
Registered
2019-03-11
Start date
2018-11-14
Completion date
2027-11-14
Last updated
2021-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burkitt Lymphoma (BL)), Diffuse Large B Lymphoma (DLBCL), Follicular Lymphoma (FL), Hodgkin's Lymphoma (HL), Mantle Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), T-cell Lymphoma (T-NHL)

Keywords

lymphoma, real life, cohort, epidemiology, PRO

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

Interventions

OTHERReal-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

Sponsors

The Lymphoma Academic Research Organisation
CollaboratorOTHER
Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Progression-Free Survival (PFS)5 years

Secondary

MeasureTime frame
Number of patients included per month in total and according to subtype of lymphoma5 years
Number of patients in each region in total and according to subtype of lymphoma9 years
Progression-Free Survival (PFS)9 years
Event-Free Survival (EFS)5 years
Overall Survival (OS)5 years
Net Survival5 years
Response rate5 years
Time to Next Anti-Lymphoma Treatment (TTNLT)5 years
Duration of Survival after progression5 years
Frequency of Lymphoma transformations5 years
Frequency of Second cancers5 years
Frequency of other chronic disease5 years
Number of exposure factorsBaseline
Number of comorbiditiesBaseline
Duration of response5 years

Other

MeasureTime frameDescription
Representativeness of the included population5 yearsStudy 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).

Countries

France

Contacts

Primary ContactHervé Ghesquières, MD
herve.ghesquieres@chu-lyon.fr04 78 86 43 40
Backup ContactAlain Monnereau, MD
A.Monnereau@bordeaux.unicancer.fr05 56 33 33 33

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026