NCT04194112

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

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

April 1, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2019

Completed
Last Updated

December 12, 2019

Status Verified

December 1, 2019

Enrollment Period

4.3 years

First QC Date

December 7, 2019

Last Update Submit

December 11, 2019

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance of IUC

    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.

    It was assessed 48 hours after primary TURBT

Secondary Outcomes (1)

  • 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 )

Study Arms (1)

NMIBC patients

OTHER

Patients with primary or recurrent NMIBC for whom complete TURBT was done.

Diagnostic Test: immediate urine cytology

Interventions

immediate urine cytologyDIAGNOSTIC_TEST

Forty-eight hours after primary TURBT, IUC was retrieved and patients were scheduled for repeat TURBT 2 to 6 weeks later according to the predetermined protocol. The primary outcome was to determine the role of positive IUC to predict positive biopsy findings on repeat TURBT.

NMIBC patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 7, 2019

First Posted

December 11, 2019

Study Start

April 1, 2015

Primary Completion

August 1, 2019

Study Completion

September 1, 2019

Last Updated

December 12, 2019

Record last verified: 2019-12