Clinical trial NCT04947618: Efficacy of Patient Management for Lymphoma Diagnosed at Nimes University Hospital From 1999 to 2018. DVR-Lym-Nim
Official title: Evaluation of the Efficacy of Management of Patients With Lymphomas Diagnosed at Nimes University Hospital Over 20 Years (1999-2018) Under Real-life Circumstances
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma, Malignant
Keywords: -Lymphoma
Mantle-Cell
Follicular
Hodgkin
T-cell
Primitive Cerebral
Marginal Zone
Waldenström's macroglobulinemia
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 400
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population consists of patients with lymphomas (Malignant Non-Hodgkinien and Hodgkin Lymphomas) diagnosed at Nîmes University Hospital from 1999 onwards and for whom the frozen biological samples are available. Since 2005, all patients have been registered in the Tumototek software program. Those diagnosed before this date can be found in the hospital's anatomopathological laboratory registers.

Brief summary: Observation of a cohort of 400 patients with different types of lymphomas.

Detailed description: A database on 400 patients diagnosed with lymphomas was built up over 20 years at Nîmes University Hospital. Biopsies were made on these tumours and all the samples were frozen.

Considering the heterogeneous nature of lymphomas, randomized clinical trials based on very precise criteria for the inclusion or non-inclusion of patients are the gold standard for studying the various sub-types of lymphomas by concentrating on homogeneous populations for which a limited number of parameters are analyzed simultaneously. However, due to the complexity of their medical situation, many patients may be excluded form these trials, thus making it difficult to obtain reliable results.

The analysis of a non-selected cohort has two main advantages: (1) to better understand the diversity of patients with lymphomas for which the recommendations are constantly evolving and (2) to analyze how, exactly, these are managed by integrating points which are currently poorly evaluated such as comorbidities and accessibility to treatment.

The aim of the study is to describe how these patients are managed and to demonstrate that not all patients are able to benefit from the official management recommendations applicable to their pathology.

Eligibility criteria: Inclusion Criteria:

* Patients over the age of 15 years and 3 months, diagnosed with lymphoma at Nîmes University Hospital as from 1999 onwards and for whom diagnostic tumor material is available.

Exclusion Criteria:

* Patients aged 18 or over who have expressed their desire not to take part in the study.
* Patients under the age of 18 whose legal representatives have expressed their desire for the child not to take part in the study.
* Patients under legal guardianship.

Primary outcomes:
measure: Overall survival rate among patients with Hodgkin Lymphomas
timeFrame: 2 years after inclusion
measure: Overall survival rate among patients with Mantle-cell Lymphomas
timeFrame: 2 years after inclusion
measure: Overall survival rate among patients with Primitive Cerebral Lymphomas
timeFrame: 2 years after inclusion
measure: Overall survival rate among patients with Follicular Lymphomas
timeFrame: 2 years after inclusion
measure: Overall survival rate among patients with Marginal Zone Lymphomas
timeFrame: 2 years after inclusion
measure: Overall survival rate among patients with Waldenström's Disease
timeFrame: 2 years after inclusion
Secondary outcomes:
measure: Differences between management of patients with Hodgkin Lymphomas actually observed and data described in the literature.
timeFrame: 2 years after inclusion
measure: Differences between management of patients with Mantle-cell Lymphomas and data described in the literature.
timeFrame: 2 years after inclusion
measure: Differences between management of patients with Primitive Cerebral Lymphomas and data described in the literature.
timeFrame: 2 years after inclusion
measure: Differences between management of patients with Follicular Lymphomas and data described in the literature.
timeFrame: 2 years after inclusion
measure: Differences between management of patients with Marginal Zone Lymphomas and data described in the literature.
timeFrame: 2 years after inclusion
measure: Differences between management of patients with Waldenström's Disease and data described in the literature.
timeFrame: 2 years after inclusion
measure: Reasons for differences between management of patients with Hodgkin Lymphomas actually observed and data described in the literature.
timeFrame: 2 years after inclusion
measure: Reasons for differences between management of patients with Mantle-cell Lymphomas actually observed and data described in the literature.
timeFrame: 2 years after inclusion
measure: Reasons for differences between management of patients with Primitive Cerebral Lymphomas actually observed and data described in the literature.
timeFrame: 2 years after inclusion
measure: Reasons for differences between management of patients with Follicular Lymphomas actually observed and data described in the literature.
timeFrame: 2 years after inclusion
measure: Reasons for differences between management of patients with Marginal Zone Lymphomas actually observed and data described in the literature.
timeFrame: 2 years after inclusion
measure: Reasons for differences between management of patients with Waldenström's Disease actually observed and data described in the literature.
timeFrame: 2 years after inclusion
measure: Analysis of the efficacy of treatment of patients with Hodgkin Lymphomas.
timeFrame: 2 years after inclusion
measure: Analysis of the efficacy of treatment of patients with Mantle-cell Lymphomas
timeFrame: 2 years after inclusion
measure: Analysis of the efficacy of treatment of patients with Primitive Cerebral Lymphomas
timeFrame: 2 years after inclusion
measure: Analysis of the efficacy of treatment of patients with Follicular Lymphomas
timeFrame: 2 years after inclusion
measure: Analysis of the efficacy of treatment of patients with Marginal Zone Lymphomas
timeFrame: 2 years after inclusion
measure: Analysis of the efficacy of treatment of patients with Waldenström's Disease
timeFrame: 2 years after inclusion
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
affiliation: CHU de Nîmes (Nîmes University Hospital)
name: Anissa MEGZARI
role: STUDY_CHAIR
References: