Living Conditions After Non-Hodgkin's Lymphoma in France

Non-hodgkin's Lymphoma Clinical Trial

— LymphoVie 2  

Official title:

Living Conditions After Non-Hodgkin's Lymphoma in France

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05583318
• Other study ID #: MAYNADIE 2022
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Marc MAYNADIE
• Phone: 03 80 39 30 48
• Email: Marc.Maynadie[@]u-bourgogne.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3209
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-hodgkin's Lymphoma

Intervention

Other:
• Data collection
Data from hematological malignancy registries
• Questionnaires
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.

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	Update of vital status (part 1)	December 2022
Primary	Generic SF-12 questionnaire	Mesure of the quality of life (part 2)	October 2024
Primary	Specific QLQ-C30 questionnaire	Mesure of the quality of life (part 2)	October 2024