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

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
immediate urine cytology
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bladder Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    NMIBC patients

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    The secondary outcome included the evaluation of predictive capacity of IUC for tumor recurrence in the study participants.
    The secondary outcome included the evaluation of predictive capacity of IUC for tumor recurrence in the study participants.

    Full Information

    First Posted
    December 7, 2019
    Last Updated
    December 11, 2019
    Sponsor
    Mansoura University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04194112
    Brief Title
    Diagnostic Performance and Predictive Capacity of Immediate Urine Cytology After Transurethral Resection of Non-Muscle Invasive Bladder Cancer; A Prospective Study
    Official Title
    Diagnostic Performance and Predictive Capacity of Immediate Urine Cytology After Transurethral Resection of Non-Muscle Invasive Bladder Cancer; A Prospective Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2015 (Actual)
    Primary Completion Date
    August 1, 2019 (Actual)
    Study Completion Date
    September 1, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mansoura University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bladder Cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    198 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    NMIBC patients
    Arm Type
    Other
    Arm Description
    Patients with primary or recurrent NMIBC for whom complete TURBT was done.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    immediate urine cytology
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Diagnostic performance of IUC
    Description
    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.
    Time Frame
    It was assessed 48 hours after primary TURBT
    Secondary Outcome Measure Information:
    Title
    The secondary outcome included the evaluation of predictive capacity of IUC for tumor recurrence in the study participants.
    Description
    The secondary outcome included the evaluation of predictive capacity of IUC for tumor recurrence in the study participants.
    Time Frame
    Within duration of follow up (4 years )

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: -patients with primary or recurrent NMIBC for whom complete TURBT was done Exclusion Criteria: -Patients with concomitant CIS, upper tract urothelial tumors, biopsy proven muscle invasion, or low risk NMIBC (single, primary, Ta, G1 tumor).

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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