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

U

University Hospital Center (CHU) Dijon Bourgogne

Status

Completed

Conditions

Non-hodgkin's Lymphoma

Treatments

Other: Questionnaires
Other: Data collection

Study type

Observational

Funder types

Other

Identifiers

NCT05583318
MAYNADIE 2022

Details and patient eligibility

About

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.

Enrollment

1,570 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

1,570 participants in 2 patient groups

Part 1: Patients diagnosed with non-Hodgkin's lymphoma
Description:
Diagnosis period 2010-2018, from the hematological malignancy registries of Côte-d'Or, Gironde, Basse-Normandie
Treatment:
Other: Data collection
Part 2: Patients diagnosed with live non-Hodgkin's lymphoma after vital status update
Description:
Update of vital status in December 2022
Treatment:
Other: Questionnaires

Trial contacts and locations

1

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Central trial contact

Marc MAYNADIE

Data sourced from clinicaltrials.gov

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