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Living Conditions After Non-Hodgkin's Lymphoma in France

Living Conditions After Non-Hodgkin's Lymphoma in France

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05583318
Acronym
LymphoVie 2
Enrollment
1570
Registered
2022-10-17
Start date
2023-09-01
Completion date
2023-11-01
Last updated
2025-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-hodgkin's Lymphoma

Brief 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. 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.

Interventions

OTHERData collection

Data from hematological malignancy registries

OTHERQuestionnaires

9 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.

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Progression-free survivalDecember 2022Update of vital status (part 1)
Generic SF-12 questionnaireOctober 2024Mesure of the quality of life (part 2)
Specific QLQ-C30 questionnaireOctober 2024Mesure of the quality of life (part 2)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026