Diagnostic Performance and Predictive Capacity of Immediate Urine Cytology After Transurethral Resection of Non-Muscle Invasive Bladder Cancer; A Prospective Study

Not Applicable

Completed

• Conditions: Bladder Cancer
• Interventions: Diagnostic Test: immediate urine cytology

• Registration Number: NCT04194112
• Lead Sponsor: Mansoura University

Brief Summary

The current study aimed at prospectively assessing the performance of IUC as a predictive tool for residual tumor after primary TURBT of NMIBC, and possible future recurrence.

Detailed Description

The current study aimed at prospectively assessing the performance of IUC as a predictive tool for residual tumor after primary TURBT of NMIBC, and possible future recurrence.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-04-01
• Primary Completion: 2019-08-01
• Study Completion: 2019-09-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-07
• Study First Submitted QC: 2019-12-07
• Study First Posted: 2019-12-11
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

-patients with primary or recurrent NMIBC for whom complete TURBT was done

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Exclusion Criteria

-Patients with concomitant CIS, upper tract urothelial tumors, biopsy proven muscle invasion, or low risk NMIBC (single, primary, Ta, G1 tumor).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NMIBC patients	immediate urine cytology	Patients with primary or recurrent NMIBC for whom complete TURBT was done.

Primary Outcome Measures

Name	Time	Method
Diagnostic performance of IUC	It was assessed 48 hours after primary TURBT	The primary outcome included assessment of the performance of IUC as a predictive tool for possible residual malignancy after primary TURBT. Thereafter, sensitivity (Sn), specificity (Sp), positive and negative predictive values (PPV, NPV) and overall accuracy of IUC as a preliminary step before repeat TURBT will be determined.

Secondary Outcome Measures

Name	Time	Method
The secondary outcome included the evaluation of predictive capacity of IUC for tumor recurrence in the study participants.	Within duration of follow up (4 years )	The secondary outcome included the evaluation of predictive capacity of IUC for tumor recurrence in the study participants.