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

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.

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Key information

Conditions

Bladder Cancer Disease Attributes Disease Progression Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Recurrent Bladder Cancer Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravesical BCG instillation

Procedure

ıntravesical BCG instillations were done two weeks after transurethral resection of bladder cancer

Primary outcomes

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

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

Sponsors and collaborators

Lead sponsor

Ankara Training and Research Hospital

Other

Registry information

Important dates

Study start: 2007
Primary completion: 2016
Study completion: 2016
First posted: Jun 5, 2017
Registry last updated: Jun 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed