跳至主要内容
临床试验/NCT02338427
NCT02338427已完成不适用

Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis. Multicenter Prospective

Centre Hospitalier Departemental Vendee2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2016年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
2
主要终点
Identification success of amylose by immunohistochemistry and proteomic analysis

研究概览

简要总结

Amyloidosis is involved in many rare diseases in relation to the diversity of amyloid proteins involved in the formation of abnormal tissue deposits. There are approximately 30 proteins involved in amylose's constitution. The therapeutic management varies depending on the type of amyloidosis observed.

The application of conventional techniques immunolabeling of amylose does not allow the comprehensive characterization of amylose forms, due to failures of the technic, the false positivity of some results, or lack of frozen tissue available for typing light chain (lambda, kappa).

In this study, the main objective is the comparison of two capacity of amylose characterisation: immunohistochemistry and proteomics analysis.

The purpose of this study is to validate the superiority of proteomic analysis by demonstrating the improvement of the precision, the reduction of technical failure, as well as the correction of erroneous diagnosis, authorizing a more adapted therapeutic management.

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
否

入选标准

  • •Upper age to 18 years
  • •Amylose diagnosis establish by tissue sample, after "Rouge Congo" coloration
  • •All patient with amylose identified by the two laboratory of anatomopathology
  • •Sample necessary for realized proteomic analysis
  • •No opposition at the participation of the study
  • •Patient sign an informed consent for biology collection

排除标准

  • •Tissue sample inadequate for apply immunohistochemistry or proteomic identification
  • •Patient trust, guardianship, under legal protection measure, deprived of freedom

研究组 & 干预措施

proteomic

Experimental

干预措施: Immunohistochemistry (Other)

proteomic

Experimental

干预措施: Proteomic analysis (Other)

结局指标

主要结局

Identification success of amylose by immunohistochemistry and proteomic analysis

时间窗: Inclusion

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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