Bladder Cancer Clinical Trial
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
NCT number | NCT01166230 |
Other study ID # | PC B305/E10 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 2010 |
Est. completion date | December 2010 |
Verified date | March 2019 |
Source | Photocure |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 551 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Austria | AKH, Klinik für Urologie der Universität Wien | Wien | |
Canada | Kingston General Hospital | Kingston | Ontario |
Canada | CHUQ Hotel-Dieu de Quebec | Quebec | |
Germany | University Clinic of Giessen, Department of Urology | Giessen | |
Germany | Klinikum der Universität München-Großhardern, Urologische Klinik und Poliklinik | München | |
Germany | Urologische Klinik München-Planegg | Planegg | |
Germany | Akadem. Lehrkrankenhaus der Uni Regensburg, Klinik für Urologie | Regensburg | |
Germany | Universitätsklinik Tuebingen, Universitätsklinik für Urologie | Tuebingen | |
Netherlands | Department of Urology, Academic Medical Center, University of Amsterdam | Amsterdam | |
Netherlands | Department of Urology, UMC St. Radboud | Nijmegen | |
United States | The Emory Clinic, Dept of Urology | Atlanta | Georgia |
United States | Boston University School of Medicine | Boston | Massachusetts |
United States | V.A. Medical Center | Gainesville | Florida |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Baylor College of Medicine, Scott Department of Urology | Houston | Texas |
United States | The University of Texas MD Anderson cancer center | Houston | Texas |
United States | University of Miami School of Medicine | Miami | Florida |
United States | Vanderbilt University Medical Center, Department of Urologic Surgery | Nashville | Tennessee |
United States | Mount Sinai Medical Center, Department of Urology | New York | New York |
United States | South Florida Clinical Research Center, Inc. | Pembroke Pines | Florida |
United States | Thomas Jefferson Medical College, Department of Neurology | Philadelphia | Pennsylvania |
United States | URMC | Rochester | New York |
United States | Urologic Clinical Research Unit, Gonda 7102, Mayo Clinic Rochester | Rochester | Minnesota |
United States | Stanford Cancer Center, Department of Urology | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Photocure |
United States, Austria, Canada, Germany, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Longer-term Recurrence-free Rates After Hexvix (Cysview) and Non-Hexvix (Cysview) Cystoscopy/TURB | 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. | up to 5.5 years retrospectively | |
Other | Median Time to Recurrence | up to 4.5 years | ||
Primary | Recurrence Free Survival | up to 4.5 years | ||
Secondary | Rate of Progression | Only patients with Ta/T1 were included in the follow-up study. "Progression" is defined as presence of T2-T4 tumors, with or without carcinoma in situ (CIS), at worst recurrence. | 4.5 years |
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