Effusion PleuralNCT04279327
Cell Block Immunohistochemistry in Effusion Cytology
An observational study of Effusion Pleural and Ascites, run by Assiut University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Effusion Pleural, Ascites, Pericardial Effusion
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all cases that have serous effusion of undiagnosed underlying aetiology.
Who may be able to join
- all cases with serous effusion of unknown aetiology including ascites, pleural or pericardial effusions.
Who cannot join
- No exclusion criteria from the histopathologist perspective, i.e. all cases that undergone diagnostic aspiration are eligible for the study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Effusion Pleural, Ascites, Pericardial Effusion
- Keywords
- immunohistochemistry, cytology, moc 31 monoclonal antibody, human
- Medical subject headings
- Pleural Effusion, Ascites, Pericardial Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cases | cytology positive for malignancy | |
| controls | cytology negative for malignancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of EZH2
sensitivity and specificity of EZH2 for diagnosis of malignancy
Measured: within 48 hours
Diagnostic performance of claudin4
sensitivity and specificity of claudin-4 for diagnosis of malignancy
Measured: within 48 hours
Diagnostic performance of MOC-31
sensitivity and specificity of MOC-31 for diagnosis of malignancy
Measured: within 48 hours
Secondary outcomes (1)
Prevalence of malignancy among cases presenting with effusion
percentage of cases diagnosed with malignancy among all cases presenting with effusion
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start1 Apr 2020
- Primary completionApr 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effusion PleuralStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Elhosainy Mohammad Mahmoud, Assiut University
- Investigators
- Aliaa EM Mahmoud, MSc, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279327
- Sponsor's protocol ID
- immuno-cytology001
- Status last verified
- Jul 2020
- First submitted
- 19 Feb 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30156768
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Cell Block Immunohistochemistry in Effusion Cytology
- ClinicalTrials.gov ID
- NCT04279327
- Acronym / sponsor ID
- immuno-cytology001
- Conditions
- Effusion Pleural, Ascites, Pericardial Effusion
- Keywords
- immunohistochemistry, cytology, moc 31 monoclonal antibody, human
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | –cytology positive for malignancy |
| controls | – | –cytology negative for malignancy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all cases that have serous effusion of undiagnosed underlying aetiology.
Key inclusion criteria (1 listed)
- all cases with serous effusion of unknown aetiology including ascites, pleural or pericardial effusions.
Key exclusion criteria (1 listed)
- No exclusion criteria from the histopathologist perspective, i.e. all cases that undergone diagnostic aspiration are eligible for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Prevalence of malignancy among cases presenting with effusion
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Background: PubMed 30156768Sundling 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aliaa EM Mahmoud, MSc principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Effusion Pleural and Ascites, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aliaa EM Mahmoud, MSc (+201007508736, aliaa.elhosainy88@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of EZH2 (time frame: within 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04279327, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.