Diffuse Large Cell Diffuse LymphomaLymphoViNCT04859920
Living Conditions of Patients With Diffuse Large B-Cell Lymphoma or Follicular Lymphoma in the Côte d'Or Region
An observational study of Diffuse Large Cell Diffuse Lymphoma and Follicular Lymphoma, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The development of new diagnostic tools and targeted therapy have significantly improved the management of non-Hodgkin's malignant lymphomas and thus their long-term prognosis. However, in the study of improved patient management, survival is not the only measurable indicator and preservation of quality of life is an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large Cell Diffuse Lymphoma, Follicular Lymphoma
- What is being tested?
- Questionnaires and Collection of clinical data and treatments
- How many people
- 157 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to 30 Apr 2021
- 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
- Adult, Older adult
Study population: Diffuse large cell diffuse B lymphoma Follicular Lymphoma
Who may be able to join
- Patients diagnosed with DLBCL or FL between January 1, 2010 and December 31, 2017,
- Alive as of January 1, 2021,
- Updated patient address.
Who cannot join
- Other forms of Hematologic Malignancies at diagnosis,
- Minors.
- Person subject to legal protection (curatorship, guardianship)
- Person subject to a judicial safeguard measure
- Pregnant, parturient or breastfeeding woman
- Adults incapable of giving consent
Trial locations and contacts
1 site in 1 country.
About this study
The development of new diagnostic tools and targeted therapy have significantly improved the management of non-Hodgkin's malignant lymphomas and thus their long-term prognosis. However, in the study of improved patient management, survival is not the only measurable indicator and preservation of quality of life is an essential component. In addition, there is little existing data regarding the determinants of quality of life in patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) in the general population in France.
- Being tested
- Questionnaires, Collection of clinical data and treatments
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
QLQ-C30, SF-12, HADS, SARASON, EPICES, socio-professional data
Collection of clinical data and treatmentsOther
clinical data and treatments
What is being measured
The primary outcome is the main question the study is designed to answer.
Generic Questionnaire SF-12
Measured: At inclusion
Specific questionnaire QLQ-C30
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Mar 2021
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large Cell Diffuse 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
- 157 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
- NCT04859920
- Sponsor's protocol ID
- MAYNADIE 2020
- Acronym
- LymphoVi
- Status last verified
- Jan 2022
- First submitted
- 22 Apr 2021
- Last updated
- 1 Feb 2023
- 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 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living Conditions of Patients With Diffuse Large B-Cell Lymphoma or Follicular Lymphoma in the Côte d'Or Region
- ClinicalTrials.gov ID
- NCT04859920
- Acronym / sponsor ID
- LymphoVi / MAYNADIE 2020
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 26 Apr 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.
The development of new diagnostic tools and targeted therapy have significantly improved the management of non-Hodgkin's malignant lymphomas and thus their long-term prognosis. However, in the study of improved patient management, survival is not the only measurable indicator and preservation of quality of life is an essential component. In addition, there is little existing data regarding the determinants of quality of life in patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) in the general population in France.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Diffuse large cell diffuse B lymphoma Follicular Lymphoma
Key inclusion criteria (3 listed)
- Patients diagnosed with DLBCL or FL between January 1, 2010 and December 31, 2017,
- Alive as of January 1, 2021,
- Updated patient address.
Key exclusion criteria (6 listed)
- Other forms of Hematologic Malignancies at diagnosis,
- Minors.
- Person subject to legal protection (curatorship, guardianship)
- Person subject to a judicial safeguard measure
- Pregnant, parturient or breastfeeding woman
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 |
|---|---|---|
| QuestionnairesQLQ-C30, SF-12, HADS, SARASON, EPICES, socio-professional data | Other | – |
| Collection of clinical data and treatmentsclinical data and treatments | Other | – |
Primary outcome
Generic Questionnaire SF-12
Time frame: At inclusion
Specific questionnaire QLQ-C30
Time frame: At inclusion
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 1 Feb 2023.
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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 Diffuse Large Cell Diffuse Lymphoma and Follicular 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 3 inclusion and 6 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 1 Feb 2023. 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?
Generic Questionnaire SF-12 (time frame: At inclusion). The study lists 2 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 1 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.