NCT03869619招募中不适用
REAL WORLD DATA IN LYMPHOMA AND SURVIVAL IN ADULTS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6,000
- 试验地点
- 37
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
REALYSA cohort is a population-based epidemiological platform in real-life for lymphomas designed to enrich prognostic data, by integrating together epidemiological, clinical and biological data.
REALYSA is a platform perfectly set up to
- Study prognostic factors using integrated epidemiological and biological data (genetics), to better characterize the determinants of refractoriness and relapse in patients with lymphoma, to follow the growing number of survivors and describe median to long-term sequela, second cancer, quality of life (QoL)...
- Document treatment effectiveness in real life and observance
- Address socio-economical questions
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
- •Signature of the consent form for participation in the REALYSA cohort
- •Aged over 18 at the time of inclusion
- •Diagnosed with lymphoma in the last 6 months (180 days)
- •Lymphoma subtype belonging to at least one of the 7 histological subtypes: diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, T-cell lymphoma, Hodgkin's lymphoma, Burkitt lymphoma
排除标准
- •Anti-lymphoma treatment already received (except pre-phase: typically corticosteroids, vincristine, cyclophosphamide, etoposide, alone or in combination)
- •Documented HIV infection
- •Any other lymphoma subtype not included in the list in Appendix
- •Of note, are excluded:
- •Chronic lymphocytic leukemia/small lymphocytic lymphoma
- •Hairy cell leukemia and variant
- •Lymphoplasmacytic lymphoma
- •Waldenström macroglobulinemia
- •Primary DLBCL of the central nervous system (CNS)
- •T-cell large granular lymphocytic leukemia
- •Chronic lymphoproliferative disorder of NK cells
- •Mycosis fungoides
- •Sézary syndrome
- •Primary cutaneous T cell lymphomas (mainly diagnosed and treated by dermatologists)
- •Post-transplant lymphoproliferative disorders (PTLD)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 5 years
次要结局
- Frequency of Second cancers(9 years)
- Frequency of other chronic disease(9 years)
- Number of patients included per month in total and according to subtype of lymphoma(5 years)
- Net Survival(9 years)
- Response rate(9 years)
- Duration of response(9 years)
- Number of patients in each region in total and according to subtype of lymphoma(9 years)
- Progression-Free Survival (PFS)(9 years)
- Event-Free Survival (EFS)(9 years)
- Overall Survival (OS)(9 years)
- Duration of Survival after progression(9 years)
- Time to Next Anti-Lymphoma Treatment (TTNLT)(9 years)
- Frequency of Lymphoma transformations(9 years)
- Number of exposure factors(Baseline)
- Number of comorbidities(Baseline)
研究者
研究点 (37)
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