跳至主要内容
临床试验/NCT03984721
NCT03984721已完成不适用

Amyloidosis Typing Using Mass Spectrometry-based Proteomics: a New Accurate Tool for Difficult Typing

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2019年7月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
2
主要终点
Amyloidosis typing

研究概览

简要总结

The main objective is to establish that a new technique of amyloidosis typing by Proteomics (based on nanoLC-MS/MS mass spectrometry) allows typing in > 90% of observations in patients whose Amyloidosis is reported to have failed typing (impossible typing, uncertain or inconsistent) with the traditional anatomopathological approach, and this in a cohort of 40 patients identified consecutively in the Department of pathological anatomy and cytology of the University Hospital of Toulouse and included prospectively.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Amyloidosis by Red Congo staining and birefringence in polarized light on tissue sampling
  • Immunolabeling Amyloidosis typing
  • impossible (no frozen sample available)
  • or inconclusive (doubtful)
  • or inconsistent with clinical, biological, genetic and iconographic data
  • Signature of the informed consent form

排除标准

  • Insufficient tissue material to perform the new technique
  • Person placed under judicial protection
  • Pregnant and breastfeeding women

结局指标

主要结局

Amyloidosis typing

时间窗: Day 0

Amyloidosis typing rate with the new technique

次要结局

  • Time to return the result(Day 0)
  • Concordance(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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