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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04279327
Other study ID # immuno-cytology001
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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