Optimized Treatment Strategy for HighGrade1 (HGT1) Bladder Cancer Based on Substaging: a Prospective Observational Cohort Study

Completed

• Conditions: Bladder Cancer

• Registration Number: NCT02113501
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

Non-muscle invasive bladder cancer of High Grade stage T1 (HGT1), has up to 20% risk of progression to invasive disease. Because the depth of substaging seems to identify two separate groups with different progression risk (HighGradeT1a and HighGradeT1b), we design a differential treatment strategy for each group. The main hypothesis is that HighGradeT1a bladder cancer can spare a second endoscopic procedure.

Detailed Description

Only cases of initial diagnosis of HighGradeT1 and with a complete transurethral endoscopic resection (TUR) of bladder tumor) can enter this protocol. HighGradeT1a will only receive standard BCG treatment (induction and maintenance). HighGradeT1b will undergo a second transurethral endoscopic resection (TUR) after the induction of Bacillus de Calmette-Guerin (BCG) and then continue mantenaince BCG and standard follow-up.

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2014-03-31
• Status Verified: 2014-04
• Study First Submitted QC: 2014-04-10
• Last Update Submitted: 2014-04-10
• Study First Posted: 2014-04-14
• Last Update Posted: 2014-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• HGT1 bladder cancer at initial diagnosis and after a complete TUR

Exclusion Criteria

• abscence of muscularis propria in the TUR specimen

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
progression	5year

Secondary Outcome Measures

Name	Time	Method
recurrence	5year

Trial Locations

Locations (1)

Hospital Vall d'Hebron, Barcelona, Spain; 🇪🇸 Barcelona, Spain