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

Study Overview
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Brief Summary
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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
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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.

Conditions
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Bladder Cancer, Disease Progression, Recurrent Bladder Cancer

Intervention / Treatment
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* Procedure: Intravesical BCG instillation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Whole patient group (patients not treated with BCG and patients treated with BCG) | Procedure: Intravesical BCG instillation<br>* ıntravesical BCG instillations were done two weeks after transurethral resection of bladder cancer<br>|
| No Intervention: Group 2<br>Patients not treated with BCG | |
| Active Comparator: Group 3<br>Patients treated with BCG | Procedure: Intravesical BCG instillation<br>* ıntravesical BCG instillations were done two weeks after transurethral resection of bladder cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence or progression | The primary end point for recurrence was accepted as the occurrence of the first recurrence or progression | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EORTC, CUETO, bladder neoplasm, disease progression, recurrence