Ascites Clinical Trial
Official title:
Diagnostic Value of Cell Block Immunohistochemistry in Effusion Cytology
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.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Assiut University Hospital | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
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
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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