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

Hospital Universitari Vall d'Hebron Research Institute200 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Bladder Cancer

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * HGT1 bladder cancer at initial diagnosis and after a complete TUR Exclusion Criteria: * abscence of muscularis propria in the TUR specimen

Locations (1)

Hospital Vall d'Hebron, Barcelona, Spain

Barcelona, Barcelona, Spain

Outcomes

Primary Outcomes

progression

Time frame: 5year

Secondary Outcomes

recurrence

Time frame: 5year

Data from ClinicalTrials.gov

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