NCT04914442

Brief 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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Status
completed

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

Study Start

First participant enrolled

January 17, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
Last Updated

June 4, 2021

Status Verified

June 1, 2021

Enrollment Period

4 years

First QC Date

June 3, 2021

Last Update Submit

June 3, 2021

Conditions

Urinary Bladder Diseases

Outcome Measures

Primary Outcomes (1)

  • 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

    1 day

Interventions

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

Eligibility Criteria

Age10 Years - 90 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from Al-Azhar Hospital Urology outpatient and inpatient clinic during 4 years ftarting from January 2017

You may qualify if:

  • Clinically suspected urothelial neoplasia

You may not qualify if:

  • Patients who did not complete the follow up period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Bladder Diseases

Interventions

Microscopy

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Abdulkarim Hasan

    Al-Azhar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Laboratory manager

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 4, 2021

Study Start

January 17, 2017

Primary Completion

January 15, 2021

Study Completion

January 20, 2021

Last Updated

June 4, 2021

Record last verified: 2021-06