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

NCT03174912 | Completed Phase 4

• 1 other identifier: 5050
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bladder Cancer; Disease Progression; Recurrent Bladder Cancer

Keywords

EORTC; CUETO; bladder neoplasm; disease progression; recurrence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Group 1

ACTIVE COMPARATOR

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

Procedure: Intravesical BCG instillation

Group 2

NO INTERVENTION

Patients not treated with BCG

Group 3

ACTIVE COMPARATOR

Patients treated with BCG

Procedure: Intravesical BCG instillation

Interventions

Intravesical BCG instillation PROCEDURE

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

Group 1; Group 3

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Training and Research Hospital: lead

Related Publications (2)

• 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.

  PMID: 23982601 RESULT

• 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.

  PMID: 23759377 RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Disease Progression; Recurrence

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Medical doctor

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: June 5, 2017
• Study Start: January 1, 2007
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: June 5, 2017

Record last verified: 2017-05