Know Cancer

or
forgot password

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


N/A
18 Years
N/A
Open (Enrolling)
Both
Bladder Cancer

Thank you

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 CenterHackensack, New Jersey  07601
Boston University School of MedicineBoston, Massachusetts  02118
University of Miami School of MedicineMiami, Florida  33136
Stanford Cancer Center, Department of UrologyStanford, California  94305-5820
V.A. Medical CenterGainesville, Florida  32608
South Florida Clinical Research Center, Inc.Pembroke Pines, Florida  33028
The Emory Clinic, Dept of UrologyAtlanta, Georgia  30322
Urologic Clinical Research Unit, Gonda 7102, Mayo Clinic RochesterRochester, Minnesota  55905
Mount Sinai Medical Center, Department of UrologyNew York, New York  10029-6574
URMCRochester, New York  14642
Thomas Jefferson Medical College, Department of NeurologyPhiladelphia, Pennsylvania  19107
Vanderbilt University Medical Center, Department of Urologic SurgeryNashville, Tennessee  37232-2765
Baylor College of Medicine, Scott Department of UrologyHouston, Texas  77030-2726