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

NCT02113501 | Completed

• 1 other identifier: HighGradeT1 Bladder Cancer HVH
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

HGT1; high risk bladder cancer; substaging; repeat transurethral resection (reTUR); lamina propria

Outcome Measures

Primary Outcomes (1)

• progression

  5year

Secondary Outcomes (1)

• recurrence

  5year

Other Outcomes (1)

• Cancer specific survival

  5year

Study Arms (2)

HGT1a

HGT1a bladder cancer patients will undergo BCG induction and maintenance followed by conventional follow-up (cystoscopy and cytology at 3months and then every 6months).

HGT1b

HGT1b bladder cancer patients will undergo a 2nd TUR after BCG induction. If negative, continue with maintenance BCG followed by conventional follow-up (cystoscopy and cytology every 6months).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Initial HGT1 bladder cancer patients that have undergone a complete TUR and are willing to enter the protocol.

You may qualify if:

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

You may not qualify if:

• abscence of muscularis propria in the TUR specimen

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Vall d'Hebron, Barcelona, Spain

Barcelona, Barcelona, 08035, Spain

Location

Related Publications (1)

• Orsola A, Cecchini L, Raventos 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-Guerin therapy and the decision for a repeat TUR. BJU Int. 2010 Jan;105(2):202-7. doi: 10.1111/j.1464-410X.2009.08694.x. Epub 2009 Jun 24.

  PMID: 19558557 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

paraffin embedded blocks of transurethral resection (TUR) samples

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Anna Orsola, MD

  Hospital Vall d'Hebron, Barcelona, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: April 14, 2014
• Study Start: April 1, 2005
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 14, 2014

Record last verified: 2014-04

Locations

ES (1)