NCT04279327

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

February 19, 2020

Last Update Submit

July 7, 2020

Conditions

Effusion PleuralAscitesPericardial Effusion

Keywords

immunohistochemistrycytologymoc 31 monoclonal antibody, human

Outcome Measures

Primary Outcomes (3)

  • Diagnostic performance of EZH2

    sensitivity and specificity of EZH2 for diagnosis of malignancy

    within 48 hours

  • Diagnostic performance of claudin4

    sensitivity and specificity of claudin-4 for diagnosis of malignancy

    within 48 hours

  • Diagnostic performance of MOC-31

    sensitivity and specificity of MOC-31 for diagnosis of malignancy

    within 48 hours

Secondary Outcomes (1)

  • Prevalence of malignancy among cases presenting with effusion

    one year

Study Arms (2)

cases

cytology positive for malignancy

controls

cytology negative for malignancy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

all cases that have serous effusion of undiagnosed underlying aetiology.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

RECRUITING

Related 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.

    PMID: 30156768BACKGROUND

MeSH Terms

Conditions

Pleural EffusionAscitesPericardial Effusion

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • Aliaa EM Mahmoud, MSc

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aliaa EM Mahmoud, MSc

CONTACT

+201007508736aliaa.elhosainy88@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Lecturer

Study Record Dates

First Submitted

February 19, 2020

First Posted

February 21, 2020

Study Start

April 1, 2020

Primary Completion

April 1, 2021

Study Completion

January 1, 2022

Last Updated

July 8, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)