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临床试验/NCT03966105
NCT03966105已完成不适用

Prevalence of Amyloidosis in Patients With Lumbar Spinal Stenosis

Oncology Institute of Southern Switzerland1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
94
试验地点
1
主要终点
Report the prevalence of ATTRwt in patients with CTS and/or LSS.

研究概览

简要总结

Prospective, observational, single-centre, non-interventional study aiming at reporting the prevalence of ATTRwt in patients with lumbar spinal stenosis (LSS).

详细描述

The study will include patients that receive surgical management and treatment for LSS, and will consist in the prospective, longitudinal collection of peripheral blood, urine samples, tissue biopsies and clinical data. The results of the project could provide a future benefit for patients with the same condition by: i) identifying accessible and sensitive biomarkers for the identification of patients at risk for having an underlying ATTRwt; ii) optimizing the therapeutic strategies in an era of innovative but cost-intensive treatments; iii) provide the proof of principle for a regular follow-up of patients who eventually will become symptomatic for overt organ ATTRwt involvement; and iv) providing the rationale for future studies based on early access disease-modifying approaches.

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
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female ≥ 50 years-old with indication of surgery treatment according to local standards for Lumbar spinal stenosis (LSS) confirmed by MRI
  • Availability of the baseline and follow-up annotations
  • Informed consent will be obtained from the patient before any study related procedures

排除标准

  • Previous diagnosis of amyloidosis

结局指标

主要结局

Report the prevalence of ATTRwt in patients with CTS and/or LSS.

时间窗: 2 years

Prevalence of ATTRwt in a prospective population.

次要结局

未报告次要终点

研究者

发起方
Oncology Institute of Southern Switzerland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Adalgisa Condoluci

MD, Resident Physician

Oncology Institute of Southern Switzerland

研究点 (1)

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