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临床试验/NCT05958134
NCT05958134已完成不适用

Brazilian Reality in the Diagnosis and Treatment of Diffuse Large B Cell Lymphoma - BRA-DLBCL: Multicenter Retrospective Study (Real World Evidence - RWE)

AstraZeneca1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2023年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
AstraZeneca
入组人数
600
试验地点
1
主要终点
Time between diagnosis and start of treatment

研究概览

简要总结

National, multicenter, non-randomized, retrospective observational study (Real World Evidence-RWE) to analyze the epidemiological profile of diffuse large B cell lymphoma, clinical management, treatment in molecular subgroups, progression profile and patient survival outcomes enrolled and treated within the last 6 years (2017 to 2022), in national cancer reference centers.

详细描述

Diffuse large B-cell lymphoma management is a challenge in clinical setting, as the heterogeneity of conditions due to the molecular complexity of DLBCL may limit treatment response. Other major factor is that in Brazil we lack evidence of treatment response profiling regarding this molecular complexity. To know the epidemiological profile of DLBCL, together with the first-line treatment profile that has been adopted in reference centers, as well as the management of relapsing, is essentially important in generating evidence that add up to actions targeting the improvement of patient care, providing them with better treatments. The Brazilian reality of clinical presentation, management profile, employed treatments and response rate is little known. Considering the Brazilian reality of a continental country, where healthcare services in reference centers present heterogeneous realities, analyzing clinical routine data may generate important evidence (RWE) to comprise the understanding on treatments effectiveness. Generated evidence has the potential to help understanding the reality of Brazilian patients, as well as supporting new regional researches.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female;
  • Age above 18 years old;
  • Diagnosis of diffuse large B-cell lymphoma (DLBCL) and high-grade non-Hodgkin B-cell lymphoma at all stagings;
  • Lymphoma classified for the cell of origin (GCB - Germinal Center B-Cell lymphoma, and non-germinal center);
  • Having first life of treatment information available in institutional medical record;
  • Having survival data available in institutional medical record.

排除标准

  • No medical record of the molecular subgroup classification;
  • Diagnosis of diffuse large B-cell lymphoma, confirmed in the year 2016;
  • Patients diagnosed with Transformed Lymphomas.

结局指标

主要结局

Time between diagnosis and start of treatment

时间窗: Time Frame: 6 years (Time of retrospective observational analysis of the study)

Description of the time between diagnosis and start of treatment

Progression-free Survival

时间窗: Time Frame: 6 years (Time of retrospective observational analysis of the study)

Progression-free Survival will be evaluated as the time from the beginning of treatment, considering each line of treatment, to the objective progression of tumor or death

Disease staging

时间窗: Time Frame: 6 years (Time of retrospective observational analysis of the study)

Description of the staging of diffuse large B-cell lymphoma conditions in patients followed in Brazilian reference cancer treatment centers

Overall Survival

时间窗: Time Frame: 6 years (Time of retrospective observational analysis of the study)

Overall Survival will be evaluated as the time from the diagnosis of the hematological disease at any staging until all-cause death

次要结局

未报告次要终点

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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