The Effect of Post-voiding Reisdual Urine on Non-muscle I... | NCT04617743

Studies
The Effect of Post-voiding Reisdual Urine on Non-muscle Invasive Bladder Cancer Recurrence and Progression

NCT04617743

Sponsor

Istanbul Medeniyet University

Status

Unknown status

Last Update Posted

Apr 12, 2022Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Bladder Cancer Recurrent
Non-Invasive Bladder Urothelial Carcinoma

Interventions

Not provided

Countries

Turkey (Türkiye)

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

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 26, 2020Actual

Primary Completion Date

Nov 1, 2021Actual

Completion Date

Nov 1, 2022Estimated

First Submitted Date

Nov 2, 2020

First Submission Date that Met QC Criteria

Nov 2, 2020

First Posted Date

Nov 5, 2020Actual

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

Apr 10, 2022

Last Update Posted Date

Apr 12, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mehmet Caglar Cakici, Department of Urology, Istanbul Medeniyet UniversityPrincipal Investigator

Lead Sponsor

Istanbul Medeniyet UniversityOTHER

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Although transurethral resection is the main treatment option for stage Ta and T1 disease, relapse is frequently detected. Tumor number, tumor size, T stage, presence of in situ carcinoma and tumor grade are risk factors for recurrence. The relationship between post voiding residual urine volume and bladder tumor recurrence and progression has not been clearly established. The investigators aimed to examine the effect of high post voiding residual urine volume on recurrence and progression based on the hypothesis that tumor cells circulating in the bladder may increase with excess residual urine.

Detailed Description

Although transurethral resection is the main treatment option for stage Ta and T1 disease, relapse is frequently detected. Tumor number, tumor size, T stage, presence of in situ carcinoma and tumor grade are risk factors for recurrence. The relationship between post voiding residual urine volume and bladder tumor recurrence and progression has not been clearly established. Participants who underwent transurethral resection for bladder tumor will be included in the study. The investigators aimed to examine the effect of high post voiding residual urine volume on recurrence and progression based on the hypothesis that tumor cells circulating in the bladder may increase with excess residual urine.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High residual volume		Bladder tumor patients with high residual volume
Low residual volume		Bladder tumor patients with low residual volume

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence	Non-muscle invasive bladder cancer recurrence rate	1 year

Secondary Outcomes

Measure	Description	Time Frame
Progression	Non-muscle invasive bladder cancer progression rate	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with transitional cell non-muscle invasive bladder cancer (NMIBC) pathology
Patients with a diagnosis of Bladder cancer (NMIBC)
Patients undergoing transurethral resection for bladder cancer (NMIBC)
≥18 years old patients

Exclusion Criteria:

Non-transitional cell bladder cancers
Patients with muscle-invasive bladder cancer pathology
<18 years old patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with transitional cell non-muscle invasive bladder cancer pathology and patients with follow-up data

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mehmet Caglar Cakici, M.D.	Contact	+90 5376102438		mcaglarcakici@hotmail.com

Overall Officials

Name	Affiliation	Role
Mehmet Caglar Cakici, M.D.	Istanbul Medeniyet University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Health Sciences University, Dıskapi Yildirim Beyazit Training and Research Hospital	Recruiting	Ankara			Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31522458	Result	Sazuka T, Sakamoto S, Nakamura K, Imamura Y, Yamamoto S, Komiya A, Ichikawa T. Impact of post-void residual urine volume on intravesical recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma. Int J Urol. 2019 Dec;26(12):1106-1112. doi: 10.1111/iju.14103. Epub 2019 Sep 14.
32875619	Result

ID	Term
D001749	Urinary Bladder Neoplasms
D012008	Recurrence
D000093284	Non-Muscle Invasive Bladder Neoplasms
D018450	Disease Progression

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms