跳至主要内容
临床试验/NCT04839003
NCT04839003招募中不适用

A Registry to Investigate Real-world Natural History, Impact of Therapies and Patterns of Progression of AL Amyloidosis (ReAL)

Fondazione IRCCS Policlinico San Matteo di Pavia1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2020年2月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
5,000
试验地点
1
主要终点
Creation of a registry of patients with AL amyloidosis

研究概览

简要总结

The purpose of this protocol is to generate a large registry of patients with AL amyloidosis.

详细描述

Thanks to this registry, it will be possible to collect data at diagnosis and during follow up, in order to be able to describe the natural history of AL amyloidosis in a real-world setting and to define and validate prognostic models, response and relapse criteria applicable at any point of the disease.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of systemic AL amyloidosis;
  • treatment-naïve (pre-treatment data collected at participating center available for retrospective part);
  • age ≥18 years;
  • ability to understand and willingness to sign an informed consent (patients who already sign informed consent for clinical data to be used in retrospective analyses will be accepted);
  • planned (or ongoing) follow-up at participating center.

排除标准

  • non-AL amyloidosis;
  • previous treatment for AL amyloidosis.

结局指标

主要结局

Creation of a registry of patients with AL amyloidosis

时间窗: 5 years

次要结局

未报告次要终点

研究者

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giovanni Palladini

Principal Investigator

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (1)

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