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In the Prediction of Recurrence and Progression of NMIBC; EORTC or CUETO or Both?

Primary Purpose

Bladder Cancer, Disease Progression, Recurrent Bladder Cancer

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Intravesical BCG instillation
Sponsored by
Ankara Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring EORTC, CUETO, bladder neoplasm, disease progression, recurrence

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • primary or recurrent bladder cancer
  • non-muscle invasive bladder cancer
  • at least 60 months follow-up period if progression was not determined.

Exclusion Criteria:

  • primary CIS,
  • muscle-invasive disease after second look TUR-BT
  • non-urothelial carcinoma of the bladder,
  • concomitant upper urinary tract tumor,
  • not able to contacted for whatever reason

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    No Intervention

    Active Comparator

    Arm Label

    Group 1

    Group 2

    Group 3

    Arm Description

    Whole patient group (patients not treated with BCG and patients treated with BCG)

    Patients not treated with BCG

    Patients treated with BCG

    Outcomes

    Primary Outcome Measures

    Recurrence or progression
    The primary end point for recurrence was accepted as the occurrence of the first recurrence or progression

    Secondary Outcome Measures

    Full Information

    First Posted
    May 29, 2017
    Last Updated
    May 31, 2017
    Sponsor
    Ankara Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03174912
    Brief Title
    In the Prediction of Recurrence and Progression of NMIBC; EORTC or CUETO or Both?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2007 (Actual)
    Primary Completion Date
    December 31, 2016 (Actual)
    Study Completion Date
    December 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ankara Training and Research Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    Investigators aimed to evaluate the performance of The European Organization for Research and Treatment of Cancer(EORTC) and the Spanish Urology Association for Oncological Treatment(CUETO) risk tables on all non-muscle invasive bladder cancer patients(NMIBC), and those not treated with BCG and treated with BCG separately.
    Detailed Description
    Risk tables can be used for the prediction of recurrence and especially progression of nonmuscle invasive bladder cancer .The European Organization for Research and Treatment of Cancer(EORTC) developed a risk table,which provides a scoring system for recurrence and progression risk.The EORTC risk table includes these factors: number of tumors,tumor size,prior recurrence rate,T stage,presence of carcinoma in situ(CIS),and grade for NMIBC patients not treated by maintenance bacillus Calmette-Guerin(BCG) instillation therapy.The Spanish Urology Association for Oncological Treatment(CUETO)later proposed a modified model to be used for patients only treated with BCG instillation.This risk table includes these factors:age,gender,recurrent tumor,number of tumors,T stage,CIS,and grade. There is no risk table that can be used for NMIBC patients treated or not treated with BCG.Should we use the EORTC risk table for patients not treated with BCG and the CUETO table only for those treated with BCG or is one of them sufficient to predict recurrence and progression in all patients?The main aim of this study was to compare the utility of the EORTC and CUETO risk tables in all patients, and separately in patients not treated with BCG and treated with BCG.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bladder Cancer, Disease Progression, Recurrent Bladder Cancer
    Keywords
    EORTC, CUETO, bladder neoplasm, disease progression, recurrence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    400 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Active Comparator
    Arm Description
    Whole patient group (patients not treated with BCG and patients treated with BCG)
    Arm Title
    Group 2
    Arm Type
    No Intervention
    Arm Description
    Patients not treated with BCG
    Arm Title
    Group 3
    Arm Type
    Active Comparator
    Arm Description
    Patients treated with BCG
    Intervention Type
    Procedure
    Intervention Name(s)
    Intravesical BCG instillation
    Intervention Description
    ıntravesical BCG instillations were done two weeks after transurethral resection of bladder cancer
    Primary Outcome Measure Information:
    Title
    Recurrence or progression
    Description
    The primary end point for recurrence was accepted as the occurrence of the first recurrence or progression
    Time Frame
    From date of participitant recruitment until the date of first documented progression or recurrence or death from any cause, whichever came first, assessed up to 60 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: primary or recurrent bladder cancer non-muscle invasive bladder cancer at least 60 months follow-up period if progression was not determined. Exclusion Criteria: primary CIS, muscle-invasive disease after second look TUR-BT non-urothelial carcinoma of the bladder, concomitant upper urinary tract tumor, not able to contacted for whatever reason

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    23982601
    Citation
    Xylinas E, Kent M, Kluth L, Pycha A, Comploj E, Svatek RS, Lotan Y, Trinh QD, Karakiewicz PI, Holmang S, Scherr DS, Zerbib M, Vickers AJ, Shariat SF. Accuracy of the EORTC risk tables and of the CUETO scoring model to predict outcomes in non-muscle-invasive urothelial carcinoma of the bladder. Br J Cancer. 2013 Sep 17;109(6):1460-6. doi: 10.1038/bjc.2013.372. Epub 2013 Aug 27.
    Results Reference
    result
    PubMed Identifier
    23759377
    Citation
    Xu T, Zhu Z, Zhang X, Wang X, Zhong S, Zhang M, Shen Z. Predicting recurrence and progression in Chinese patients with nonmuscle-invasive bladder cancer using EORTC and CUETO scoring models. Urology. 2013 Aug;82(2):387-93. doi: 10.1016/j.urology.2013.04.007. Epub 2013 Jun 10.
    Results Reference
    result

    Learn more about this trial

    In the Prediction of Recurrence and Progression of NMIBC; EORTC or CUETO or Both?

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