Cell Block Immunohistochemistry in Effusion Cytology

Ascites Clinical Trial

Official title:

Diagnostic Value of Cell Block Immunohistochemistry in Effusion Cytology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04279327
• Other study ID #: immuno-cytology001
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: January 2022

Study information

• Verified date: July 2020
• Source: Assiut University
• Contact: Aliaa EM Mahmoud, MSc
• Phone: +201007508736
• Email: aliaa.elhosainy88[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2022
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Ascites
• Effusion Pleural
• Pericardial Effusion

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Sundling KE, Cibas ES. Ancillary studies in pleural, pericardial, and peritoneal effusion cytology. Cancer Cytopathol. 2018 Aug;126 Suppl 8:590-598. doi: 10.1002/cncy.22021. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic performance of EZH2	sensitivity and specificity of EZH2 for diagnosis of malignancy	within 48 hours
Primary	Diagnostic performance of claudin4	sensitivity and specificity of claudin-4 for diagnosis of malignancy	within 48 hours
Primary	Diagnostic performance of MOC-31	sensitivity and specificity of MOC-31 for diagnosis of malignancy	within 48 hours
Secondary	Prevalence of malignancy among cases presenting with effusion	percentage of cases diagnosed with malignancy among all cases presenting with effusion	one year