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NCT Number: NCT02113501

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

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.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Vall d'Hebron, Barcelona, Spain

Barcelona, 08035, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • abscence of muscularis propria in the TUR specimen

Treatment and study plan

Primary outcomes

  1. progression

    Time frame: 5year

Secondary outcomes

  1. recurrence

    Time frame: 5year

Other outcomes

  1. Cancer specific survival

    Time frame: 5year

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2013
Study completion
2013
First posted
Apr 14, 2014
Registry last updated
Apr 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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