跳至主要内容
临床试验/NCT04279327
NCT04279327Unknown不适用

Diagnostic Value of Cell Block Immunohistochemistry in Effusion Cytology

Assiut University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Diagnostic performance of MOC-31

研究概览

简要总结

Cytology is usually the first step in investigating serous effusions, to either detect or exclude an underlying malignancy. This study will try to answer the need for improved diagnostic yield of cytologic examination by cell block technique and immunohistochemical testing of three markers which are EZH2, Claudin-4 and MOC-31.

详细描述

This is a prospective study that will be conducted at the pathology lab of Assiut University Hospital. The study will include effusion specimens (pleural, peritoneal & pericardial) and the aspirated fluid will be examined for physical characters e.g. color and appearance.

The sample will be divided into 2 equal parts: one for conventional smear preparation, and the other for cell block. A minimum of 2 thin smears will be prepared and stained with Papanicolou stain.

Cell block sections of 4-6 μ thickness will be prepared and stained with the hematoxylin and eosin stain (H&E).

For immunohistochemistry, cell blocks will be used. Expression of claudin 4, EZH2, and MOC-31 will be evaluated in benign and malignant cells by using immunoperoxidase technique.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • all cases with serous effusion of unknown aetiology including ascites, pleural or pericardial effusions.

排除标准

  • No exclusion criteria from the histopathologist perspective, i.e. all cases that undergone diagnostic aspiration are eligible for the study.

结局指标

主要结局

Diagnostic performance of MOC-31

时间窗: within 48 hours

sensitivity and specificity of MOC-31 for diagnosis of malignancy

Diagnostic performance of claudin4

时间窗: within 48 hours

sensitivity and specificity of claudin-4 for diagnosis of malignancy

Diagnostic performance of EZH2

时间窗: within 48 hours

sensitivity and specificity of EZH2 for diagnosis of malignancy

次要结局

  • Prevalence of malignancy among cases presenting with effusion(one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aliaa Elhosainy Mohammad Mahmoud

Associate Lecturer

Assiut University

研究点 (1)

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