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OpenTrials
Completed

NCT Number: NCT05583318

Living Conditions After Non-Hodgkin's Lymphoma in France

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourgogne

Dijon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data Collection

Other

Data from hematological malignancy registries

questionnaires

Other

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.

Primary outcomes

  1. Progression-free survival

    Time frame: December 2022

    Update of vital status (part 1)

  2. Generic SF-12 questionnaire

    Time frame: October 2024

    Mesure of the quality of life (part 2)

  3. Specific QLQ-C30 questionnaire

    Time frame: October 2024

    Mesure of the quality of life (part 2)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: LymphoVie 2

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 17, 2022
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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