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NCT Number: NCT03869619

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

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Key information

Conditions

Diffuse Large B Lymphoma (DLBCL) Burkitt Lymphoma Burkitt Lymphoma (BL)) DNA Virus Infections Epstein-Barr Virus Infections Follicular Lymphoma (FL) Hemic and Lymphatic Diseases Herpesviridae Infections Hodgkin Disease Hodgkin's Lymphoma (HL) Immune System Diseases Immunoproliferative Disorders Infections Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Mantle Cell Lymphoma (MCL) Marginal Zone Lymphoma (MZL) Neoplasms Neoplasms by Histologic Type T-cell Lymphoma (T-NHL) Tumor Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Unité d'Hématologie Clinique, CH D'ARRAS, Arras, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Real-life epidemiological platform of lymphoma in France

Other

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

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: 5 years

Secondary outcomes

  1. Number of patients included per month in total and according to subtype of lymphoma

    Time frame: 5 years

  2. Number of patients in each region in total and according to subtype of lymphoma

    Time frame: 9 years

  3. Progression-Free Survival (PFS)

    Time frame: 9 years

  4. Event-Free Survival (EFS)

    Time frame: 5 years

  5. Event-Free Survival (EFS)

    Time frame: 9 years

  6. Overall Survival (OS)

    Time frame: 5 years

  7. Overall Survival (OS)

    Time frame: 9 years

  8. Net Survival

    Time frame: 5 years

  9. Net Survival

    Time frame: 9 years

  10. Response rate

    Time frame: 5 years

  11. Response rate

    Time frame: 9 years

  12. Duration of response

    Time frame: 5 years

  13. Duration of response

    Time frame: 9 years

  14. Time to Next Anti-Lymphoma Treatment (TTNLT)

    Time frame: 5 years

  15. Time to Next Anti-Lymphoma Treatment (TTNLT)

    Time frame: 9 years

  16. Duration of Survival after progression

    Time frame: 5 years

  17. Duration of Survival after progression

    Time frame: 9 years

  18. Frequency of Lymphoma transformations

    Time frame: 5 years

  19. Frequency of Lymphoma transformations

    Time frame: 9 years

  20. Frequency of Second cancers

    Time frame: 5 years

  21. Frequency of Second cancers

    Time frame: 9 years

  22. Frequency of other chronic disease

    Time frame: 5 years

  23. Frequency of other chronic disease

    Time frame: 9 years

  24. Number of exposure factors

    Time frame: Baseline

  25. Number of comorbidities

    Time frame: Baseline

Other outcomes

  1. Representativeness of the included population

    Time frame: 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).

  2. Representativeness of the included population

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Alain Monnereau, MD

CONTACT

[email protected]

05 56 33 33 33 ext. +33

Hervé Ghesquières, MD

CONTACT

[email protected]

04 78 86 43 40 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Collaborators

  • The Lymphoma Academic Research Organisation

Registry information

Acronym: REALYSA

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Mar 11, 2019
Registry last updated
Jun 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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