Urinary Bladder DiseasesNCT04914442
Eosinophilic Cystitis Mimicking Urothelial Neoplasia
An observational study of Urinary Bladder Diseases, run by Al-Azhar University.
Trial summary
We explored the potential etiology, clinical and histopathology presentation of the eosinophilic cystitis cases, clinically mimicking urothelial neoplasia. Surgical procedure and clinical outcome also evaluated. T Read more about this study
- Who is it for?
- Ages 10 to 90 years
- Conditions the study is for
- Urinary Bladder Diseases
- What is being tested?
- Microscopic examination
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 17 Jan 2017to 20 Jan 2021
- 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 10 to 90 years
- All sexes
- Child, Adult, Older adult
Study population: Patients from Al-Azhar Hospital Urology outpatient and inpatient clinic during 4 years ftarting from January 2017
Who may be able to join
- Clinically suspected urothelial neoplasia
Who cannot join
- Patients who did not complete the follow up period
About this study
Official title: Eosinophilic Cystitis Mimicking Urothelial Neoplasia: A Retrospective Study
We explored the potential etiology, clinical and histopathology presentation of the eosinophilic cystitis cases, clinically mimicking urothelial neoplasia. Surgical procedure and clinical outcome also evaluated. T
Read the detailed description
A pooled 22 patients diagnosed with eosinophilic cystitis on microscopic examination in our hospital during four years were retrospectively studied.We explored the potential etiology, clinical and histopathology presentation of the eosinophilic cystitis cases, clinically mimicking urothelial neoplasia. Surgical procedure and clinical outcome also evaluated. Transurethral resection of the lesions were performed and pathologically examined, we re-examined the studied cases and made a clinical correlation.
- Conditions
- Urinary Bladder Diseases
- Being tested
- Microscopic examination
- Medical subject headings
- Urinary Bladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microscopic examinationDiagnostic test
All the studies cases are microscopically examined using the ordinary stains (hematoxylin and eosin) then the eosinophilic infiltration are counted in 10 high power field manually
What is being measured
The primary outcome is the main question the study is designed to answer.
Eosinophil cell count
Each tissue slide is retrieved and examined to count the eosinphils in the submucosa, positive cases revelaed more than 90% eosinophils of the whole inflammatory cells
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start17 Jan 2017
- Primary completion15 Jan 2021
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder DiseasesStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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 only
- Time perspective
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulkarim Hasan, Al-Azhar University
- Investigators
- Abdulkarim Hasan, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914442
- Sponsor's protocol ID
- AUH210501
- Status last verified
- Jun 2021
- First submitted
- 3 Jun 2021
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eosinophilic Cystitis Mimicking Urothelial Neoplasia: A Retrospective Study
- ClinicalTrials.gov ID
- NCT04914442
- Acronym / sponsor ID
- AUH210501
- Conditions
- Urinary Bladder Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 4 Jun 2021 (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.
We explored the potential etiology, clinical and histopathology presentation of the eosinophilic cystitis cases, clinically mimicking urothelial neoplasia. Surgical procedure and clinical outcome also evaluated. T
Detailed description
A pooled 22 patients diagnosed with eosinophilic cystitis on microscopic examination in our hospital during four years were retrospectively studied.We explored the potential etiology, clinical and histopathology presentation of the eosinophilic cystitis cases, clinically mimicking urothelial neoplasia. Surgical procedure and clinical outcome also evaluated. Transurethral resection of the lesions were performed and pathologically examined, we re-examined the studied cases and made a clinical correlation.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from Al-Azhar Hospital Urology outpatient and inpatient clinic during 4 years ftarting from January 2017
Key inclusion criteria (1 listed)
- Clinically suspected urothelial neoplasia
Key exclusion criteria (1 listed)
- Patients who did not complete the follow up period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microscopic examinationAll the studies cases are microscopically examined using the ordinary stains (hematoxylin and eosin) then the eosinophilic infiltration are counted in 10 high power field manually | Diagnostic test | – |
Primary outcome
Eosinophil cell count
Time frame: 1 day
Each tissue slide is retrieved and examined to count the eosinphils in the submucosa, positive cases revelaed more than 90% eosinophils of the whole inflammatory cells
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
Abdulkarim Hasan principal investigator
Al-Azhar University
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder Diseases, run by Al-Azhar University.
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: finished, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eosinophil cell count (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2021.