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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02113501
• Other study ID #: HighGradeT1 Bladder Cancer HVH
• Status: Completed
• Phase: N/A
• First received: March 31, 2014
• Last updated: April 10, 2014
• Start date: April 2005
• Est. completion date: December 2013

Study information

• Verified date: April 2014
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación ClínicaSpain: Departament de Salut de la Generalitat de CatalunyaSpain: GCP (GCMP/ICH/135/95)Spain: Royal Decree 223/2004
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• abscence of muscularis propria in the TUR specimen

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
Spain	Hospital Vall d'Hebron, Barcelona, Spain	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Orsola A, Cecchini L, Raventós CX, Trilla E, Planas J, Landolfi S, de Torres I, Morote J. Risk factors for positive findings in patients with high-grade T1 bladder cancer treated with transurethral resection of bladder tumour (TUR) and bacille Calmette-Gu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cancer specific survival		5year	No
Primary	progression		5year	No
Secondary	recurrence		5year	No