Clinical trial NCT01166230: Longer-term Recurrence Rates in Patients With Bladder Cancer After Hexvix (Cysview)Fluorescence Cystoscopy/TURB
Official title: An Open, Non-interventional, Retrospective, Comparative, Multicenter Follow-up Study in Patients Included in the Previously Completed Clinical Study PCB305/04, to Assess Longer-term Recurrence Rates in Patients After Hexvix® (Cysview®)Fluorescence Cystoscopy/Transurethral Resection of the Bladder (TURB) or White Light Cystoscopy/TURB
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Lead sponsor: Photocure
Sponsor class: INDUSTRY
First posted: 2010-07-20
Enrollment: 551
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-invasive papillary bladder cancer, enrolled in the previously completed pivotal phase III study PC B305/04, who were followed for recurrence will be included in this study.

Brief summary: The 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 lead to a longer-term reduction in recurrences compared to standard white light cystoscopy/TURB.

Detailed description: 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.

No safety data was collected.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence Free Survival
timeFrame: up to 4.5 years
Secondary outcomes:
measure: Rate of Progression
timeFrame: 4.5 years
Other outcomes:
measure: Longer-term Recurrence-free Rates After Hexvix (Cysview) and Non-Hexvix (Cysview) Cystoscopy/TURB
timeFrame: up to 5.5 years retrospectively
measure: Median Time to Recurrence
timeFrame: up to 4.5 years
Locations:
city: Stanford
country: United States
facility: Stanford Cancer Center, Department of Urology
state: California
city: Gainesville
country: United States
facility: V.A. Medical Center
state: Florida
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Pembroke Pines
country: United States
facility: South Florida Clinical Research Center, Inc.
state: Florida
city: Atlanta
country: United States
facility: The Emory Clinic, Dept of Urology
state: Georgia
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
city: Rochester
country: United States
facility: Urologic Clinical Research Unit, Gonda 7102, Mayo Clinic Rochester
state: Minnesota
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Medical Center, Department of Urology
state: New York
city: Rochester
country: United States
facility: URMC
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson Medical College, Department of Neurology
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center, Department of Urologic Surgery
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine, Scott Department of Urology
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson cancer center
state: Texas
city: Wien
country: Austria
facility: AKH, Klinik für Urologie der Universität Wien
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Quebec
country: Canada
facility: CHUQ Hotel-Dieu de Quebec
city: Giessen
country: Germany
facility: University Clinic of Giessen, Department of Urology
city: München
country: Germany
facility: Klinikum der Universität München-Großhardern, Urologische Klinik und Poliklinik
city: Planegg
country: Germany
facility: Urologische Klinik München-Planegg
city: Regensburg
country: Germany
facility: Akadem. Lehrkrankenhaus der Uni Regensburg, Klinik für Urologie
city: Tuebingen
country: Germany
facility: Universitätsklinik Tuebingen, Universitätsklinik für Urologie
city: Amsterdam
country: Netherlands
facility: Department of Urology, Academic Medical Center, University of Amsterdam
city: Nijmegen
country: Netherlands
facility: Department of Urology, UMC St. Radboud
Study officials:
affiliation: The University of Texas MD Anderson Cancer Center
name: Herbert Barton Grossman, MD
role: PRINCIPAL_INVESTIGATOR
References: