Is the Normal Looking Bladder Mucosa on WL Cystoscopy Dur... | NCT06729346

Studies
Is the Normal Looking Bladder Mucosa on WL Cystoscopy During TURBT Really Normal and Can NBI Detect Hidden Tumor

NCT06729346

Sponsor

Armed Forces Institute of Urology, Rawalpindi

Status

Recruiting

Last Update Posted

Jan 29, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Transition Cell Cancer

Interventions

Not provided

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 28, 2024Actual

Primary Completion Date

Mar 30, 2025Estimated

Completion Date

Mar 30, 2025Estimated

First Submitted Date

Dec 7, 2024

First Submission Date that Met QC Criteria

Dec 10, 2024

First Posted Date

Dec 11, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2025

Last Update Posted Date

Jan 29, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Azmat ullah, Consultant urologist, Armed Forces Institute of Urology, RawalpindiPrincipal Investigator

Lead Sponsor

Armed Forces Institute of Urology, RawalpindiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

As every urologist does transurethral resection of bladder tumor. So there are instances in which the operating surgeon is not sure whether the normal-looking mucosa or the inflammatory changes are really benign or if we are missing the CIS/bladder cancer.

Detailed Description

This is basically the observational study. in which we want to clarify that the normal-looking mucosa on white light cystoscopy is normal in reality or we are missing CIS/bladder tumor.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to prove suspicious-looking mucosa on NBI has a bladder tumor on histopathology..		At the time of TURBT

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

any patient with bladder tumor

Exclusion Criteria:

any patient whose age is less than 18 years any patient whose age is more than 75 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

any patient who presented with armed forces institute of urology with bladder tumor .

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
azmat ullah, consultant urologist	Contact	+923329354338		azmatdawar254@gmail.com
ullah	Contact			azmatdawar254@gmail.com

Overall Officials

Name	Affiliation	Role
azmat ullah, consultant urologist	armed forces institute of urology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Armed Forces Institute of Urology	Recruiting	Rawalpindi	Punjab Province	46000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Histopathology report

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

01 January 2024 till 30 march 2024

Access Criteria

each and everyone

URL

Not provided