Optimized Treatment Strategy for HighGradeT1 (HGT1) Bladder Cancer Based on Substaging (Depth of Lamina Propria Invasion): a Prospective Observational Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bladder Cancer
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- progression
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •HGT1 bladder cancer at initial diagnosis and after a complete TUR
Exclusion Criteria
- •abscence of muscularis propria in the TUR specimen
Outcomes
Primary Outcomes
progression
Time Frame: 5year
Secondary Outcomes
- recurrence(5year)