Cell Block Immunohistochemistry in Effusion Cytology

Overview

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.

Full Title of Study: “Diagnostic Value of Cell Block Immunohistochemistry in Effusion Cytology”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: April 2021

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.

Arms, Groups and Cohorts

  • cases
    • cytology positive for malignancy
  • controls
    • cytology negative for malignancy

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Prevalence of malignancy among cases presenting with effusion
    • Time Frame: one year
    • percentage of cases diagnosed with malignancy among all cases presenting with effusion

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assiut University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Aliaa Elhosainy Mohammad Mahmoud, Associate Lecturer – Assiut University
  • Overall Official(s)
    • Aliaa EM Mahmoud, MSc, Principal Investigator, Assiut University
  • Overall Contact(s)
    • Aliaa EM Mahmoud, MSc, +201007508736, aliaa.elhosainy88@yahoo.com

References

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.

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