Living Conditions After Non-Hodgkin's Lymphoma in France

NCT05583318 | Completed

• 1 other identifier: MAYNADIE 2022
• Study Type: observational
• Target: 1,570
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

Part 2: Patients diagnosed with live non-Hodgkin's lymphoma after vital status update

Update of vital status in December 2022

Other: Questionnaires

Interventions

Data collection OTHER

Data from hematological malignancy registries

Part 1: Patients diagnosed with non-Hodgkin's lymphoma

Questionnaires OTHER

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.

Part 2: Patients diagnosed with live non-Hodgkin's lymphoma after vital status update

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with non-Hodgkin's lymphoma

You may qualify if:

• 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
• Other forms of malignant hemopathies at diagnosis,
• Minors.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, France

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Data Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 17, 2022
• Study Start: September 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)