Lymphoma, MalignantDVR-Lym-NimNCT04947618
Efficacy of Patient Management for Lymphoma Diagnosed at Nimes University Hospital From 1999 to 2018. DVR-Lym-Nim
An observational study of Lymphoma, Malignant, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Observation of a cohort of 400 patients with different types of lymphomas. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Lymphoma, Malignant
- How many people
- 136 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2024to 29 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Observation of a cohort of 400 patients with different types of lymphomas.
Read the 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.
- Conditions
- Lymphoma, Malignant
- Keywords
- Mantle-Cell, Follicular, Hodgkin, T-cell, Primitive Cerebral, Marginal Zone, Waldenström's macroglobulinemia, lymphoma
- Medical subject headings
- Lymphoma, Waldenstrom Macroglobulinemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years after inclusion
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.
Measured: 2 years after inclusion
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.
Measured: 2 years after inclusion
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.
Measured: 2 years after inclusion
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.
Measured: 2 years after inclusion
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.
Measured: 2 years after inclusion
Secondary outcomes (18)
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.
Measured: 2 years after inclusion
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.
Measured: 2 years after inclusion
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.
Measured: 2 years after inclusion
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.
Measured: 2 years after inclusion
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.
Measured: 2 years after inclusion
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.
Measured: 2 years after inclusion
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
Measured: 2 years after inclusion
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
Measured: 2 years after inclusion
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
Measured: 2 years after inclusion
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
Measured: 2 years after inclusion
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
Measured: 2 years after inclusion
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
Measured: 2 years after inclusion
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.
Measured: 2 years after inclusion
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.
Measured: 2 years after inclusion
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.
Measured: 2 years after inclusion
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.
Measured: 2 years after inclusion
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.
Measured: 2 years after inclusion
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.
Measured: 2 years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start22 Jan 2024
- Primary completion29 Jun 2026
- Study completion29 Jun 2026
Why it stopped: The doctor retired and there's no one to take over the project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, MalignantStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anissa MEGZARI, Study chair, CHU de Nîmes (Nîmes University Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947618
- Sponsor's protocol ID
- NIMAO/2019-01/EJ-01
- Acronym
- DVR-Lym-Nim
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2021
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04947618
- Acronym / sponsor ID
- DVR-Lym-Nim / NIMAO/2019-01/EJ-01
- Conditions
- Lymphoma, Malignant
- Keywords
- Mantle-Cell, Follicular, Hodgkin, T-cell, Primitive Cerebral, Marginal Zone, Waldenström's macroglobulinemia, lymphoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The doctor retired and there's no one to take over the project
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 29 Jun 2026 (actual)
- Study completion
- 29 Jun 2026 (actual)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival rate among patients with Hodgkin Lymphomas
Time frame: 2 years after inclusion
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.
Overall survival rate among patients with Mantle-cell Lymphomas
Time frame: 2 years after inclusion
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.
Overall survival rate among patients with Primitive Cerebral Lymphomas
Time frame: 2 years after inclusion
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.
Overall survival rate among patients with Follicular Lymphomas
Time frame: 2 years after inclusion
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.
Overall survival rate among patients with Marginal Zone Lymphomas
Time frame: 2 years after inclusion
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.
Overall survival rate among patients with Waldenström's Disease
Time frame: 2 years after inclusion
If the patient has died, the date of death recorded in the hospital file or from the INSERM CépiDC register will be noted.
18 secondary outcomes
Differences between management of patients with Hodgkin Lymphomas actually observed and data described in the literature.
Time frame: 2 years after inclusion
Differences between management of patients with Mantle-cell Lymphomas and data described in the literature.
Time frame: 2 years after inclusion
Differences between management of patients with Primitive Cerebral Lymphomas and data described in the literature.
Time frame: 2 years after inclusion
Differences between management of patients with Follicular Lymphomas and data described in the literature.
Time frame: 2 years after inclusion
Differences between management of patients with Marginal Zone Lymphomas and data described in the literature.
Time frame: 2 years after inclusion
Differences between management of patients with Waldenström's Disease and data described in the literature.
Time frame: 2 years after inclusion
Reasons for differences between management of patients with Hodgkin Lymphomas actually observed and data described in the literature.
Time frame: 2 years after inclusion
Reasons for differences between management of patients with Mantle-cell Lymphomas actually observed and data described in the literature.
Time frame: 2 years after inclusion
Reasons for differences between management of patients with Primitive Cerebral Lymphomas actually observed and data described in the literature.
Time frame: 2 years after inclusion
Reasons for differences between management of patients with Follicular Lymphomas actually observed and data described in the literature.
Time frame: 2 years after inclusion
Reasons for differences between management of patients with Marginal Zone Lymphomas actually observed and data described in the literature.
Time frame: 2 years after inclusion
Reasons for differences between management of patients with Waldenström's Disease actually observed and data described in the literature.
Time frame: 2 years after inclusion
Analysis of the efficacy of treatment of patients with Hodgkin Lymphomas.
Time frame: 2 years after inclusion
Analysis of the efficacy of treatment of patients with Mantle-cell Lymphomas
Time frame: 2 years after inclusion
Analysis of the efficacy of treatment of patients with Primitive Cerebral Lymphomas
Time frame: 2 years after inclusion
Analysis of the efficacy of treatment of patients with Follicular Lymphomas
Time frame: 2 years after inclusion
Analysis of the efficacy of treatment of patients with Marginal Zone Lymphomas
Time frame: 2 years after inclusion
Analysis of the efficacy of treatment of patients with Waldenström's Disease
Time frame: 2 years after inclusion
Results and safety
The study was stopped early (reason given: The doctor retired and there's no one to take over the project). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anissa MEGZARI study chair
CHU de Nîmes (Nîmes University Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, Malignant, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The doctor retired and there's no one to take over the project). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival rate among patients with Hodgkin Lymphomas (time frame: 2 years after inclusion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.