Cell Block Immunohistochemistry in Effusion Cytology

Diagnostic Value of Cell Block Immunohistochemistry in Effusion Cytology

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04279327

Enrollment

100

Registered

2020-02-21

Start date

2020-04-01

Completion date

2022-01-31

Last updated

2020-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ascites, Effusion Pleural, Pericardial Effusion

Keywords

immunohistochemistry, cytology, moc 31 monoclonal antibody, human

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* No

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Prevalence of malignancy among cases presenting with effusion	one year	percentage of cases diagnosed with malignancy among all cases presenting with effusion

Countries

Egypt

Contacts

Primary ContactAliaa EM Mahmoud, MSc

aliaa.elhosainy88@yahoo.com+201007508736

Outcome results