The Italian Transthyretin Amyloidosis Web-Network (ITA-WebNet)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Establishing an online tool for data-sharing, available for health care providers
研究概览
简要总结
The study aims, by generating a large registry of patients with ATTR amyloidosis, including data at diagnosis and during follow up, to describe the natural history of ATTR amyloidosis in a real-world setting and to define and validate prognostic models, response criteria applicable at any point of the disease. The registry will also be used for data sharing and to allow the possibility of a close collaboration amongst the amyloidosis experts of the ARTC and all the physicians around the Country involved in the diagnosis and management of systemic amyloidosis. Thanks to the online registry, the diagnostic facility of the ARTC will be made available to requesting physicians.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- 否
入选标准
- •Suspected diagnosis of systemic and localized amyloidosis;
- •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
- •Diagnosis of light chain (AL) amyloidosis
结局指标
主要结局
Establishing an online tool for data-sharing, available for health care providers
时间窗: 5 years
Different data (types type of organ involvement, biomarkers of organ damage, date of onset of symptoms, date of diagnosis, type of treatment (if any)) will be shared between the health-care professionals and the panel of experts.
次要结局
未报告次要终点
研究者
Paolo Milani
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia