REal World Data in LYmphoma and Survival in Adults

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospices Civils de Lyon

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Anti-lymphoma treatment already received (except pre-phase: typically corticosteroids, vincristine, cyclophosphamide, etoposide, alone or in combination)

Documented HIV infection

Chronic lymphocytic leukemia/small lymphocytic lymphoma

Hairy cell leukemia and variant

Trial population

Patients diagnosed with lymphoma in the last 6 months.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Real-life epidemiological platform of lymphoma in France

    Other intervention

    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

Treatment groups

6,000 Participants
are divided into 1 treatment group
Group A: All enrolled patients1 intervention

Trial outcomes

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

Other outcomes

1

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).

Time frame
5 years
2

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).

Time frame
9 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospices Civils de Lyon

Lead sponsor

The Lymphoma Academic Research Organisation

Collaborator