Living Conditions After Non-Hodgkin's Lymphoma in France
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,570
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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,
排除标准
- •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.
结局指标
主要结局
Progression-free survival
时间窗: December 2022
Update of vital status (part 1)
Generic SF-12 questionnaire
时间窗: October 2024
Mesure of the quality of life (part 2)
Specific QLQ-C30 questionnaire
时间窗: October 2024
Mesure of the quality of life (part 2)
次要结局
未报告次要终点