An Open, Non-interventional, Retrospective, Comparative, Multicenter Follow-up Study in Patients Included in the Previously Completed Clinical Study pc b305/04, to Assess a Longer-term Recurrence Rates in Patients After Hexvix® (Cysview®)Fluorescence Cystoscopy/Turb or White Light Cystoscopy/TURB
18 Years
N/A
Both
Bladder Cancer
Trial Information
An Open, Non-interventional, Retrospective, Comparative, Multicenter Follow-up Study in Patients Included in the Previously Completed Clinical Study pc b305/04, to Assess a Longer-term Recurrence Rates in Patients After Hexvix® (Cysview®)Fluorescence Cystoscopy/Turb or White Light Cystoscopy/TURB
A previously completed pivotal clinical study PC B305/04 demonstrated reduced recurrence
rates for patients with papillary bladder cancer who underwent Hexvix (Cysview) and white
light cystoscopy and transurethral resection (TURB) of the bladder compared to patients who
underwent white light cystoscopy and TURB alone.
The present study is intended to investigate whether the improved initial detection and
resection of bladder cancer lesions in patients with non-muscle invasive bladder cancer with
Hexvix (Cysview) fluorescence cystoscopy/TURB will also lead to a longer-term reduction in
recurrences compared to standard white light cystoscopy/TURB.
Inclusion Criteria:
- Patients of study PC B305/04 with Ta or T1, that were followed for recurrence are
eligible to be included in this study.
Exclusion Criteria:
- Patient died during clinical study PC B305/04
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Retrospective
Outcome Measure:
Longer-term recurrence-free rates after Hexvix (Cysview) and non-Hexvix (Cysview) cystoscopy/TURB
Outcome Description:
To extend the follow-up period of the pivotal trial (B305/04) to up in all available patients, to assess a longer-term estimate of recurrence-free rates after Hexvix and non-Hexvix cystoscopy/TURB, and to assess numbers and types of recurrences, amount and type of treatment given, and numbers of deaths.
Outcome Time Frame:
up to 5.5 years retrospectively
Safety Issue:
No
Principal Investigator
Herbert Barton Grossman, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
The University of Texas, MD Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
PC B305/E10
NCT ID:
NCT01166230
Start Date:
June 2010
Completion Date:
December 2010
Related Keywords:
- Bladder Cancer
- Urinary Bladder Neoplasms
- Recurrence
Name | Location |
|---|---|
| Hackensack University Medical Center | Hackensack, New Jersey 07601 |
| Boston University School of Medicine | Boston, Massachusetts 02118 |
| University of Miami School of Medicine | Miami, Florida 33136 |
| Stanford Cancer Center, Department of Urology | Stanford, California 94305-5820 |
| V.A. Medical Center | Gainesville, Florida 32608 |
| South Florida Clinical Research Center, Inc. | Pembroke Pines, Florida 33028 |
| The Emory Clinic, Dept of Urology | Atlanta, Georgia 30322 |
| Urologic Clinical Research Unit, Gonda 7102, Mayo Clinic Rochester | Rochester, Minnesota 55905 |
| Mount Sinai Medical Center, Department of Urology | New York, New York 10029-6574 |
| URMC | Rochester, New York 14642 |
| Thomas Jefferson Medical College, Department of Neurology | Philadelphia, Pennsylvania 19107 |
| Vanderbilt University Medical Center, Department of Urologic Surgery | Nashville, Tennessee 37232-2765 |
| Baylor College of Medicine, Scott Department of Urology | Houston, Texas 77030-2726 |
