Efficacy of Patient Management for Lymphoma Diagnosed at Nimes University Hospital From 1999 to 2018. DVR-Lym-Nim

Lymphoma, Malignant Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04947618
• Other study ID #: NIMAO/2019-01/EJ-01
• Status: Recruiting
• Start date: January 22, 2024
• Est. completion date: January 31, 2026

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Eric JOURDAN, Dr.
• Phone: 0466684033
• Email: eric.jourdan[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observation of a cohort of 400 patients with different types of lymphomas.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Malignant

Locations

Country	Name	City	State
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival rate among patients with Hodgkin Lymphomas	The number of months during which the patient has survived since inclusion will be noted. If the patient has died, the date of death recorded in the hospital file or from the INSERM CépiDC register will be noted.	2 years after inclusion
Primary	Overall survival rate among patients with Mantle-cell Lymphomas	The number of months during which the patient has survived since inclusion will be noted.If the patient has died, the date of death recorded in the hospital file or from the INSERM CépiDC register will be noted.	2 years after inclusion
Primary	Overall survival rate among patients with Primitive Cerebral Lymphomas	The number of months during which the patient has survived since inclusion will be noted. If the patient has died, the date of death recorded in the hospital file or from the INSERM CépiDC register will be noted.	2 years after inclusion
Primary	Overall survival rate among patients with Follicular Lymphomas	The number of months during which the patient has survived since inclusion will be noted. If the patient has died, the date of death recorded in the hospital file or from the INSERM CépiDC register will be noted.	2 years after inclusion
Primary	Overall survival rate among patients with Marginal Zone Lymphomas	The number of months during which the patient has survived since inclusion will be noted. If the patient has died, the date of death recorded in the hospital file or from the INSERM CépiDC register will be noted.	2 years after inclusion
Primary	Overall survival rate among patients with Waldenström's Disease	If the patient has died, the date of death recorded in the hospital file or from the INSERM CépiDC register will be noted.	2 years after inclusion
Secondary	Differences between management of patients with Hodgkin Lymphomas actually observed and data described in the literature.	The actual management of these patients will be compared with the data in the literature and any differences will be noted.	2 years after inclusion
Secondary	Differences between management of patients with Mantle-cell Lymphomas and data described in the literature.	The actual management of these patients will be compared with the data in the literature and any differences will be noted.	2 years after inclusion
Secondary	Differences between management of patients with Primitive Cerebral Lymphomas and data described in the literature.	The actual management of these patients will be compared with the data in the literature and any differences will be noted.	2 years after inclusion
Secondary	Differences between management of patients with Follicular Lymphomas and data described in the literature.	The actual management of these patients will be compared with the data in the literature and any differences will be noted.	2 years after inclusion
Secondary	Differences between management of patients with Marginal Zone Lymphomas and data described in the literature.	The actual management of these patients will be compared with the data in the literature and any differences will be noted.	2 years after inclusion
Secondary	Differences between management of patients with Waldenström's Disease and data described in the literature.	The actual management of these patients will be compared with the data in the literature and any differences will be noted.	2 years after inclusion
Secondary	Reasons for differences between management of patients with Hodgkin Lymphomas actually observed and data described in the literature.	The reasons for any differences noted will be analyzed	2 years after inclusion
Secondary	Reasons for differences between management of patients with Mantle-cell Lymphomas actually observed and data described in the literature.	The reasons for any differences noted will be analyzed	2 years after inclusion
Secondary	Reasons for differences between management of patients with Primitive Cerebral Lymphomas actually observed and data described in the literature.	The reasons for any differences noted will be analyzed	2 years after inclusion
Secondary	Reasons for differences between management of patients with Follicular Lymphomas actually observed and data described in the literature.	The reasons for any differences noted will be analyzed	2 years after inclusion
Secondary	Reasons for differences between management of patients with Marginal Zone Lymphomas actually observed and data described in the literature.	The reasons for any differences noted will be analyzed	2 years after inclusion
Secondary	Reasons for differences between management of patients with Waldenström's Disease actually observed and data described in the literature.	The reasons for any differences noted will be analyzed	2 years after inclusion
Secondary	Analysis of the efficacy of treatment of patients with Hodgkin Lymphomas.	The following criteria for efficacy will be noted: overall survival, relapse, survival without relapse and refractory lymphomas. The histological type, treatment given and comorbidities noted will be included in the analysis.	2 years after inclusion
Secondary	Analysis of the efficacy of treatment of patients with Mantle-cell Lymphomas	The following criteria for efficacy will be noted: overall survival, relapse, survival without relapse and refractory lymphomas. The histological type, treatment given and comorbidities noted will be included in the analysis.	2 years after inclusion
Secondary	Analysis of the efficacy of treatment of patients with Primitive Cerebral Lymphomas	The following criteria for efficacy will be noted: overall survival, relapse, survival without relapse and refractory lymphomas. The histological type, treatment given and comorbidities noted will be included in the analysis.	2 years after inclusion
Secondary	Analysis of the efficacy of treatment of patients with Follicular Lymphomas	The following criteria for efficacy will be noted: overall survival, relapse, survival without relapse and refractory lymphomas. The histological type, treatment given and comorbidities noted will be included in the analysis.	2 years after inclusion
Secondary	Analysis of the efficacy of treatment of patients with Marginal Zone Lymphomas	The following criteria for efficacy will be noted: overall survival, relapse, survival without relapse and refractory lymphomas. The histological type, treatment given and comorbidities noted will be included in the analysis.	2 years after inclusion
Secondary	Analysis of the efficacy of treatment of patients with Waldenström's Disease	The following criteria for efficacy will be noted: overall survival, relapse, survival without relapse and refractory lymphomas. The histological type, treatment given and comorbidities noted will be included in the analysis.	2 years after inclusion