An International Multicenter Observational Retrospective Study on Plasmablastic Lymphoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 32
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This is an observational, multicenter, international and retrospective study, that aims to collect data on clinical and pathological characteristics, treatment regimens, outcome, and prognostic factors (clinical, biomarkers and/or radio-metabolic) in patients affected by PBL.
详细描述
This study is an International, multicenter, observational, retrospective trial on patients affected by PBL. The information collected aim to obtain data from the real-life diagnosis, staging, management and treatment and outcome of PBL patients. A centralized pathological review of pathological samples is planned to define the rate of accurate diagnosis and to define a recommended immunohistochemical diagnostic panel for PBL. In addition, exploratory analysis will be performed to better characterize PBL.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of plasmablastic lymphoma (PBL) between Jan 1st 2000, and Dec 31st 2022
- •Histologically confirmed plasmablastic lymphoma (PBL) diagnosis according to local pathological report
- •Age > 18 years old
- •Availability of complete medical records
- •Availability of histopathological material requested by the study
排除标准
- •Any other histology than PBL
- •Lack of complete medical records
- •Lack of histopathological material requested by the study
结局指标
主要结局
Overall Survival (OS)
时间窗: 36 months
OS is defined as the time from the diagnosis to death for any cause or last clinical contact for censored patients.
次要结局
- Complete remission rate (CR)(36 months)
- Splenic involvement(36 months)
- Kidney and/or adrenal gland involvement(36 months)
- ECOG-PS(36 months)
- Ann Arbor Stage(36 months)
- Diagnostic liquor(36 months)
- Type of chemotherapy (CHT) regimen(36 months)
- Overall response rate (ORR)(36 monts)
- Progression-free survival (PFS)(36 months)
- Validation of IPI and CNS-IPI score by means of Cox PH regression on OS and PFS(36 months)
- Frequencies of HIV and EBV at relapse(36 months)