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临床试验/NCT05114330
NCT05114330招募中不适用

Non-interventional, Prospective Observational Study of the Treatment Practice of CNS Involvement of Malignant Lymphoma in Routine Clinical Practice

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2011年6月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Outcome of different therapeutic regimens

研究概览

简要总结

The objective of the observation is to collect and document data on treatment strategies for secondary central nervous system lymphoma (SCNSL) in routine clinical practice, whether obtained in the context of clinical trials or outside of trials. In particular, the following questions will be specified:

  • What therapeutic approaches are being pursued?
  • What is the clinical outcome of the various treatment options?
  • What is the frequency of serious adverse events with each therapeutic approach?

详细描述

The observational study is to be conducted in inpatient clinics, outpatient clinics and by oncology physicians in private practice. The investigators will be invited to participate by the Charité - CNS Lymphoma Working Group (Charité AG ZNSL) or the Competence Network Malignant Lymphomas (KML). When a patient is reported, the personal data of the physician including the patient will be recorded and compiled in the form of a list documentation.

All patients with SCNSL can and should be included in the study regardless of which therapy options are used and regardless of whether it is a first-line treatment, the treatment of a recurrence or a maintenance therapy for SCNSL. No intervention is associated with the conduct of the observational study with regard to the selection and implementation of the specific therapeutic regimen, diagnostics, and examination frequency during and after treatment.

The following information should be documented:

  • Patient demographics and medical history
  • Tumor extent at the time of initial diagnosis and CNS involvement
  • Prior therapy
  • General condition
  • Therapy regimen for the CNS involvement
  • Response
  • Adverse drug reactions
  • Tolerability of therapy: acute toxicity
  • Chronic therapy toxicity, especially late neurotoxicity
  • Time to treatment failure (relapse or progression)
  • Death from any cause

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients with SCNSL can and should be included in the registry regardless of which treatment options are used and whether the treatment being given is first-line, recurrence, or maintenance therapy for SCNSL.

排除标准

  • 未提供

结局指标

主要结局

Outcome of different therapeutic regimens

时间窗: Through study completion, an average of 3 years

Progression Free Survival

Description of different therapeutic regimens

时间窗: Through study completion, an average of 3 years

Description of different therapeutic regimens

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefan Habringer

Principal Investigator

Charite University, Berlin, Germany

研究点 (1)

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