Cell Block Immunohistochemistry in Effusion Cytology

• Conditions: Pericardial Effusion; Effusion Pleural; Ascites

• Registration Number: NCT04279327
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-21
• Study Start: 2020-04-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-08
• Primary Completion: 2021-04
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic performance of MOC-31	within 48 hours	sensitivity and specificity of MOC-31 for diagnosis of malignancy
Diagnostic performance of claudin4	within 48 hours	sensitivity and specificity of claudin-4 for diagnosis of malignancy
Diagnostic performance of EZH2	within 48 hours	sensitivity and specificity of EZH2 for diagnosis of malignancy

Secondary Outcome Measures

Name	Time	Method
Prevalence of malignancy among cases presenting with effusion	one year	percentage of cases diagnosed with malignancy among all cases presenting with effusion

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt