Living Conditions After Non-Hodgkin's Lymphoma in France

Recruiting

• Conditions: Non-hodgkin's Lymphoma
• Interventions: Other: Data collection; Other: Questionnaires

• Registration Number: NCT05583318
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-10-13
• Study First Posted: 2022-10-17
• Study Start: 2023-09-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-19
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3209

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Part 1: Patients diagnosed with non-Hodgkin's lymphoma	Data collection	Diagnosis 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	Questionnaires	Update of vital status in December 2022

Primary Outcome Measures

Name	Time	Method
Specific QLQ-C30 questionnaire	October 2024	Mesure of the quality of life (part 2)
Progression-free survival	December 2022	Update of vital status (part 1)
Generic SF-12 questionnaire	October 2024	Mesure of the quality of life (part 2)

Trial Locations

Locations (1)

Chu Dijon Bourgogne; 🇫🇷 Dijon, France