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

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ClinicalTrials.gov Identifier: NCT03869619
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : March 11, 2019
Sponsor:
Collaborator:
The Lymphoma Academic Research Organisation
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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

Condition or disease Intervention/treatment
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)) Other: Real-life epidemiological platform of lymphoma in France

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 9 Years
Official Title: REAL WORLD DATA IN LYMPHOMA AND SURVIVAL IN ADULTS
Actual Study Start Date : November 14, 2018
Estimated Primary Completion Date : October 2027
Estimated Study Completion Date : October 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: 5 years ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with lymphoma in the last 6 months.
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03869619


Contacts
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Contact: Hervé Ghesquières, MD 04 78 86 43 40 ext +33 herve.ghesquieres@chu-lyon.fr
Contact: Alain Monnereau, MD 05 56 33 33 33 ext +33 A.Monnereau@bordeaux.unicancer.fr

Locations
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France
Institut Bergonié Not yet recruiting
Bordeaux, France
Contact: Fontanet BIJOU, MD    05 56 33 33 39 ext +33    f.bijou@bordeaux.unicancer.fr   
Principal Investigator: Fontanet BIJOU, MD         
CHU Francois MITTERRAND Not yet recruiting
Dijon, France
Contact: Cédric ROSSI, MD    03 80 29 50 41 ext +33    cedric.rossi@chu-dijon.fr   
Principal Investigator: Cédric ROSSI, MD         
CHD Vendée Not yet recruiting
La Roche-sur-Yon, France
Contact: Nadine MORINEAU, MD    02 51 44 61 73 ext +33    nadine.morineau@chd-vendee.fr   
Principal Investigator: Nadine MORINEAU, MD         
CHU Haut-Lévêque Not yet recruiting
Pessac, France
Contact: Kamal-Krimo BOUABDALLAH, MD    05 57 65 65 11 ext +33    krimo.bouabdallah@chu-bordeaux.fr   
Principal Investigator: Kamal-Krimo BOUABDALLAH, MD         
Centre Hospitalier Lyon Sud Recruiting
Pierre-Bénite, France
Contact: Hervé Ghesquières, MD    04 78 86 43 40 ext +33    herve.ghesquieres@chu-lyon.fr   
Contact: Alain Monnereau    05 56 33 33 33 ext +33    A.Monnereau@bordeaux.unicancer.fr   
Principal Investigator: Hervé Ghesquières, MD         
Hôpitaux Universitaires de Strasbourg Not yet recruiting
Strasbourg, France
Contact: Luc-Matthieu FORNECKER, MD    03 88 12 76 79 ext +33    luc-matthieu.fornecker@chru-strasbourg.fr   
Principal Investigator: Luc-Matthieu FORNECKER, MD         
Institut Universitaire du Cancer Not yet recruiting
Toulouse, France
Contact: Loïc YSEBAERT, MD    05 31 15 63 51 ext +33    ysebaert.loic@iuct-oncopole.fr   
Principal Investigator: Loïc YSEBAERT, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
The Lymphoma Academic Research Organisation
Investigators
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Study Director: Hervé Ghesquières, MD Hospices Civils de Lyon
Study Director: Alain Monnereau, MD Université de Bordeaux : Inserm
More Information
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Additional Information:

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03869619    
Other Study ID Numbers: 69HCL18_0352
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
lymphoma
real life
cohort
epidemiology
PRO
Additional relevant MeSH terms:
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Burkitt Lymphoma
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections