Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis. Multicenter Prospective
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
干预措施: Immunohistochemistry (Other)
proteomic
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
