Non-hodgkin's LymphomaLymphoVie 2NCT05583318
Living Conditions After Non-Hodgkin's Lymphoma in France
An observational study of Non-hodgkin's Lymphoma, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
This is an innovative project, allowing to study for the first time the long-term living conditions of patients after diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) from population data in France. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-hodgkin's Lymphoma
- What is being tested?
- Data collection and Questionnaires
- Type of treatment
- Pill or oral medicine
- How many people
- 1,570 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2023to 1 Nov 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with non-Hodgkin's lymphoma
Who may be able to join
- Diagnosis period 2010-2018, according to the 2008 WHO ICD-O-3 classification, from the hematological malignancy registries of Côte-d'Or, Gironde, Basse-Normandie
- Patients with a diagnosis of follicular lymphoma (9690/3, 9691/3, 9695/3, 9698/3, 9597/3)
- Patients with a diagnosis of diffuse large B-cell lymphoma (9678/3, 9679/3, 9680/3, 9684/3, 9688/3, 9712/3, 9735/3, 9737/3, 9738/3)
- For Part 2: Individuals alive at the date of vital status update
- Non-inclusion criteria:
- Other forms of malignant hemopathies at diagnosis,
- Minors.
Who cannot join
- Person under a legal protection measure (curatorship, guardianship)
- Person under a legal protection measure (guardianship, tutorship)
- Pregnant, parturient or breastfeeding women
- Major incapable or unable to express his consent
- Person who did not return the questionnaires following the 1-month follow-up, or patient who expressed refusal to participate.
Trial locations and contacts
1 site in 1 country.
About this study
This is an innovative project, allowing to study for the first time the long-term living conditions of patients after diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) from population data in France. Patients will be selected from the three specialized hematology registries in France: Côte-d'Or, Gironde and Basse-Normandie.
This is also one of the first studies to look at epidemiological indicators of net survival after diagnosis of follicular lymphoma and diffuse large B-cell lymphoma, adjusted for clinical factors such as disease stage, therapeutic management, and comorbidities, apart from the standard adjustment factors of age, sex, and time of diagnosis in real life. In addition, the proportion of cured patients will be estimated.
For component 1, this will be the survival analysis on the initial data. For part 2, questionnaires will be sent out followed by a follow-up if necessary one month after the mailing. There is no physical interview nor any specific biological or imaging examination.
- Conditions
- Non-hodgkin's Lymphoma
- Being tested
- Data collection, Questionnaires
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Data from hematological malignancy registries
QuestionnairesOther
9 questionnaires were sent out:
- QLQ-C30 and SF-12 Quality of Life Questionnaire.
- Oral quality of life questionnaire QLQ-OH15
- Sexuality questionnaire SHQ-C22
- Anxiety and depression questionnaire HADS,
- Rosenberg Self-Esteem Questionnaire
- RNLI Reintegration to Normal Life Questionnaire
- Social Support Questionnaire SSQ6,
- Socio-economic status questionnaire EPICES,
- Complementary questionnaire collecting data on socio-professional status.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Patients diagnosed with non-Hodgkin's lymphoma | Diagnosis period 2010-2018, from the hematological malignancy registries of Côte-d'Or, Gironde, Basse-Normandie Receives: Other: Data collection | |
| Part 2: Patients diagnosed with live non-Hodgkin's lymphoma after vital status update | Update of vital status in December 2022 Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Update of vital status (part 1)
Measured: December 2022
Generic SF-12 questionnaire
Mesure of the quality of life (part 2)
Measured: October 2024
Specific QLQ-C30 questionnaire
Mesure of the quality of life (part 2)
Measured: October 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start1 Sep 2023
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Prospective
- Enrolment
- 1,570 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583318
- Sponsor's protocol ID
- MAYNADIE 2022
- Acronym
- LymphoVie 2
- Status last verified
- Jul 2025
- First submitted
- 13 Oct 2022
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living Conditions After Non-Hodgkin's Lymphoma in France
- ClinicalTrials.gov ID
- NCT05583318
- Acronym / sponsor ID
- LymphoVie 2 / MAYNADIE 2022
- Conditions
- Non-hodgkin's Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,570 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 17 Oct 2022 (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.
This is an innovative project, allowing to study for the first time the long-term living conditions of patients after diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) from population data in France. Patients will be selected from the three specialized hematology registries in France: Côte-d'Or, Gironde and Basse-Normandie.
This is also one of the first studies to look at epidemiological indicators of net survival after diagnosis of follicular lymphoma and diffuse large B-cell lymphoma, adjusted for clinical factors such as disease stage, therapeutic management, and comorbidities, apart from the standard adjustment factors of age, sex, and time of diagnosis in real life. In addition, the proportion of cured patients will be estimated.
For component 1, this will be the survival analysis on the initial data. For part 2, questionnaires will be sent out followed by a follow-up if necessary one month after the mailing. There is no physical interview nor any specific biological or imaging examination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Patients diagnosed with non-Hodgkin's lymphoma | – | Other: Data collectionDiagnosis period 2010-2018, from the hematological malignancy registries of Côte-d'Or, Gironde, Basse-Normandie |
| Part 2: Patients diagnosed with live non-Hodgkin's lymphoma after vital status update | – | Other: QuestionnairesUpdate of vital status in December 2022 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-Hodgkin's lymphoma
Key inclusion criteria (7 listed)
- Diagnosis period 2010-2018, according to the 2008 WHO ICD-O-3 classification, from the hematological malignancy registries of Côte-d'Or, Gironde, Basse-Normandie
- Patients with a diagnosis of follicular lymphoma (9690/3, 9691/3, 9695/3, 9698/3, 9597/3)
- Patients with a diagnosis of diffuse large B-cell lymphoma (9678/3, 9679/3, 9680/3, 9684/3, 9688/3, 9712/3, 9735/3, 9737/3, 9738/3)
- For Part 2: Individuals alive at the date of vital status update
- Other forms of malignant hemopathies at diagnosis,
Key exclusion criteria (5 listed)
- Person under a legal protection measure (curatorship, guardianship)
- Person under a legal protection measure (guardianship, tutorship)
- Pregnant, parturient or breastfeeding women
- Major incapable or unable to express his consent
- Person who did not return the questionnaires following the 1-month follow-up, or patient who expressed refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionData from hematological malignancy registries | Other | Part 1: Patients diagnosed with non-Hodgkin's lymphoma |
| Questionnaires9 questionnaires were sent out: 1. QLQ-C30 and SF-12 Quality of Life Questionnaire. 2. Oral quality of life questionnaire QLQ-OH15 3. Sexuality questionnaire SHQ-C22 4. Anxiety and depression questionnaire HADS, 5. Rosenberg Self-Esteem Questionnaire 6. RNLI Reintegration to Normal Life Questionnaire 7. Social Support Questionnaire SSQ6, 8. Socio-economic status questionnaire EPICES, 9. Complementary questionnaire collecting data on socio-professional status. | Other | Part 2: Patients diagnosed with live non-Hodgkin's lymphoma after vital status update |
Primary outcome
Progression-free survival
Time frame: December 2022
Update of vital status (part 1)
Generic SF-12 questionnaire
Time frame: October 2024
Mesure of the quality of life (part 2)
Specific QLQ-C30 questionnaire
Time frame: October 2024
Mesure of the quality of life (part 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Non-hodgkin's Lymphoma, run by Centre Hospitalier Universitaire Dijon 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 23 Jul 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression-free survival (time frame: December 2022). The study lists 3 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 23 Jul 2025.