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
- 23
- 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
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 回顾性
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
研究组 & 干预措施
Plasmablastic lymphoma patients
Patients with diagnosis (histologically confirmed) of plasmablastic lymphoma (PBL) between Jan 1st 2000 and Dec 31st 2022
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)
- Progression-free survival (PFS)(36 months)
- ECOG-PS(36 months)
- Ann Arbor Stage(36 months)
- Kidney and/or adrenal gland involvement(36 months)
- Diagnostic liquor(36 months)
- Splenic involvement(36 months)
- Type of chemotherapy (CHT) regimen(36 months)
- Overall response rate (ORR)(36 monts)
- 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)
研究者
研究点 (23)
标识符
- NCT 编号
- NCT06781359
- 其他研究编号
- FIL_PlaLy
日期
- 首次提交
- (去年)
- 首次发布
- (去年)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
Qualified researchers may contact the FIL board at segreteriadirezione@filinf.it to share invidual-level patients' clinical data analysed for the publication article (for the avoidance of doubt, no identifiable data, such as name, address, hospital name, date of birth, or any other identifying data, will be shared and should not be requested).