Trials / Completed
CompletedNCT02113501
Optimized Treatment Strategy for HighGrade1 (HGT1) Bladder Cancer Based on Substaging: a Prospective Observational Cohort Study
Optimized Treatment Strategy for HighGradeT1 (HGT1) Bladder Cancer Based on Substaging (Depth of Lamina Propria Invasion): a Prospective Observational Cohort Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (actual)
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2005-04-01
- Primary completion
- 2013-12-01
- Completion
- 2013-12-01
- First posted
- 2014-04-14
- Last updated
- 2014-04-14
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT02113501. Inclusion in this directory is not an endorsement.