Living Conditions After Non-Hodgkin's Lymphoma in France (LymphoVie 2)

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 Overview

• Status: Recruiting
• Conditions: Non-hodgkin's Lymphoma
• Intervention / Treatment: Other: Data collection; Other: Questionnaires

• Study Type: Observational
• Enrollment (Estimated): 3209

Contacts and Locations

• Study Contact: Name: Marc MAYNADIE; Phone Number: 03 80 39 30 48; Email: Marc.Maynadie@u-bourgogne.fr

Study Locations

• France
  • Dijon, France
    • Recruiting
    • CHU Dijon Bourgogne
    • Contact: Marc MAYNADIE; Phone Number: 03 80 39 30 48; Email: Marc.Maynadie@u-bourgogne.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with non-Hodgkin's lymphoma

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Data collection; Data from hematological malignancy registries
Part 2: Patients diagnosed with live non-Hodgkin's lymphoma after vital status update; Update of vital status in December 2022	Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: MAYNADIE 2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No