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

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Trial Identification

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

Official Title: Optimized Treatment Strategy for HighGradeT1 (HGT1) Bladder Cancer Based on Substaging (Depth of Lamina Propria Invasion): a Prospective Observational Cohort Study

Study ID: NCT02113501

Conditions

Bladder Cancer

Interventions

Study Description

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.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Hospital Vall d'Hebron, Barcelona, Spain, Barcelona, , Spain

Contact Details

Name: Anna Orsola, MD

Affiliation: Hospital Vall d'Hebron, Barcelona, Spain

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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