Effect of Tumor Base Size in Bladder Cancer | NCT06632340

Studies
Effect of Tumor Base Size in Bladder Cancer

NCT06632340

Sponsor

Ankara Training and Research Hospital

Status

Completed

Last Update Posted

Oct 16, 2024Actual

Enrollment

130Actual

Phase

Not Applicable

Conditions

Bladder Cancer

Interventions

TUR-BT

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

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Actual

Primary Completion Date

Sep 30, 2023Actual

Completion Date

Jan 1, 2024Actual

First Submitted Date

Oct 7, 2024

First Submission Date that Met QC Criteria

Oct 7, 2024

First Posted Date

Oct 9, 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

Oct 13, 2024

Last Update Posted Date

Oct 16, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Arif Bedirhan Bayraktar, medical doctor, Ankara Training and Research HospitalPrincipal Investigator

Lead Sponsor

Ankara Training and Research HospitalOTHER

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

Investigators aim to investigate the effect of the size of the base of the tumor in contact with the bladder mucosa on recurrence and progression in non-muscle invasive bladder tumors.

Detailed Description

Between March 2021 and September 2023, 130 patients who applied to our clinic with complaints of hematuria, dysuria, and suprapubic pain, and who were diagnosed with bladder tumor by imaging methods and underwent TUR-MT were included in the study. The groups were compared in terms of age, gender, smoking, ASA, comorbidities, BMI and the number of tumors, size, stage as intraoperative and postoperative data. Patients with tumor base size <2 cm were classified as Group

1, while with tumor base size ≥2 cm were classified as Group 2. Kaplan Meier survival analysis without recurrence and without progression were performed after comparing the groups in terms of recurrence and progression.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Other	tumor base size <2 cm	Procedure: TUR-BT
Group 2	Other	tumor base size >2 cm	Procedure: TUR-BT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TUR-BT	Procedure	Transurethral resection of bladder tumor	Group 1 Group 2

Measure	Description	Time Frame
Recurrence		2 year

Measure	Description	Time Frame
progression		2 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Bladder Tumor

Exclusion Criteria:

Invasive Bladder Tumor

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ankara Training and Research Hospital		Ankara			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D001749	Urinary Bladder Neoplasms

Ancestor Terms

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

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Browse Branches

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