Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03174912
Recruitment Status : Completed
First Posted : June 5, 2017
Last Update Posted : June 5, 2017
Sponsor:
Information provided by (Responsible Party):
Muhammet Fatih Kilinc, Ankara Training and Research Hospital

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Disease Progression Recurrent Bladder Cancer Procedure: Intravesical BCG instillation Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : January 1, 2007
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Active Comparator: Group 1
Whole patient group (patients not treated with BCG and patients treated with BCG)
Procedure: Intravesical BCG instillation
ıntravesical BCG instillations were done two weeks after transurethral resection of bladder cancer

No Intervention: Group 2
Patients not treated with BCG
Active Comparator: Group 3
Patients treated with BCG
Procedure: Intravesical BCG instillation
ıntravesical BCG instillations were done two weeks after transurethral resection of bladder cancer




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Publications of Results:
Layout table for additonal information
Responsible Party: Muhammet Fatih Kilinc, Principal investigator, Medical doctor, Ankara Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03174912    
Other Study ID Numbers: 5050
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: June 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Muhammet Fatih Kilinc, Ankara Training and Research Hospital:
EORTC
CUETO
bladder neoplasm
disease progression
recurrence
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder Neoplasms
Disease Progression
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes