Longer-term Recurrence Rates in Patients With Bladder Cancer After Hexvix (Cysview)Fluorescence Cystoscopy/TURB
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by PhotoCure.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
PhotoCure
Information provided by:
PhotoCure
ClinicalTrials.gov Identifier:
NCT01166230
First received: July 19, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
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Purpose
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.
| Condition |
|---|
|
Bladder Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Retrospective |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by PhotoCure:
Primary Outcome Measures:
- Longer-term recurrence-free rates after Hexvix (Cysview) and non-Hexvix (Cysview) cystoscopy/TURB [ Time Frame: up to 5.5 years retrospectively ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 521 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Patients with Ta/T1 bladder cancer
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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.
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166230
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Hide Study LocationsLocations
| United States, California | |
| Stanford Cancer Center, Department of Urology | Not yet recruiting |
| Stanford, California, United States, 94305-5820 | |
| Contact: Amy Lee, CRC 650-736-0697 ajlee12@stanford.edu | |
| Principal Investigator: Joseph Presti, MD | |
| United States, Florida | |
| V.A. Medical Center | Not yet recruiting |
| Gainesville, Florida, United States, 32608 | |
| Contact: Maria Lopez, CRC 352-376-1611 ext 6952 | |
| Principal Investigator: Unyime Nseyo, MD | |
| University of Miami School of Medicine | Not yet recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Dinorah Rodriguez, CRC 305-243-7207 drodriguez5@med.miami.edu | |
| Principal Investigator: Mark Soloway, MD | |
| South Florida Clinical Research Center, Inc. | Not yet recruiting |
| Pembroke Pines, Florida, United States, 33028 | |
| Contact: Denise Weaver 954-392-7577 DWeaverRN@bellsouth.net | |
| Principal Investigator: Maury A. Jayson, MD | |
| United States, Georgia | |
| The Emory Clinic, Dept of Urology | Not yet recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Beverly Lopez, CRC 404-778-4162 Beverly_Lopez@emoryhealthcare.org | |
| Principal Investigator: Chad Ritenour, MD | |
| United States, Massachusetts | |
| Boston University School of Medicine | Not yet recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Contact: Becky Brown, CRC 617-414-1828 becky.brown@bmc.org | |
| Principal Investigator: Richard Babayan, MD | |
| United States, Minnesota | |
| Urologic Clinical Research Unit, Gonda 7102, Mayo Clinic Rochester | Enrolling by invitation |
| Rochester, Minnesota, United States, 55905 | |
| United States, New Jersey | |
| Hackensack University Medical Center | Enrolling by invitation |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Mount Sinai Medical Center, Department of Urology | Not yet recruiting |
| New York, New York, United States, 10029-6574 | |
| Contact: Lourdes Campos-Grundvig, CRC 212-241-3141 | |
| Principal Investigator: Michael Droller, MD | |
| URMC | Enrolling by invitation |
| Rochester, New York, United States, 14642 | |
| United States, Pennsylvania | |
| Thomas Jefferson Medical College, Department of Neurology | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Christine Hubert, CRC 215-955-9954 Christine.hubert@jefferson.edu | |
| Principal Investigator: Leonard Gomella, MD | |
| United States, Tennessee | |
| Vanderbilt University Medical Center, Department of Urologic Surgery | Enrolling by invitation |
| Nashville, Tennessee, United States, 37232-2765 | |
| United States, Texas | |
| Baylor College of Medicine, Scott Department of Urology | Not yet recruiting |
| Houston, Texas, United States, 77030-2726 | |
| Contact: Joy Banerjee, CRC 713-798-4479 JBanerjee@www.urol.bcm.tmc.edu | |
| Principal Investigator: Seth Lerner, MD | |
| Austria | |
| AKH, Klinik für Urologie der Universität Wien | Not yet recruiting |
| Wien, Austria, 1090 | |
| Contact: Silvia Forster +43 (1) 40400 2616 silvia.forster@meduniwien.ac.at | |
| Principal Investigator: Joerg Schmidbauer, MD | |
| Canada, Ontario | |
| Kingston General Hospital | Not yet recruiting |
| Kingston, Ontario, Canada, K7L 2V7 | |
| Contact: Sylvia Robbs, CRC 613-549-6666 ext 4778 robbs@kgh.kari.net | |
| Principal Investigator: Alvaro Morales, MD | |
| Canada | |
| CHUQ Hotel-Dieu de Quebec | Not yet recruiting |
| Quebec, Canada, G1R 2J6 | |
| Contact: Denise Hereault, CRC 418-691-5050 | |
| Principal Investigator: Yves Fradet, MD | |
| Germany | |
| University Clinic of Giessen, Department of Urology | Not yet recruiting |
| Giessen, Germany, 35392 | |
| Contact: Gerson Luedecke, MD +49 641 99 44518 Gerson.Luedecke@chiru.med.uni-giessen.de | |
| Principal Investigator: Gerson Luedecke, MD | |
| Klinikum der Universität München-Großhardern, Urologische Klinik und Poliklinik | Enrolling by invitation |
| München, Germany, 81377 | |
| Urologische Klinik München-Planegg | Not yet recruiting |
| Planegg, Germany, 82152 | |
| Contact: Karin Buchsteiner, CRC +49 89 85693 525 Buchsteiner@ukmp.de | |
| Principal Investigator: Martin Kriegmair, MD | |
| Akadem. Lehrkrankenhaus der Uni Regensburg, Klinik für Urologie | Not yet recruiting |
| Regensburg, Germany, 93053 | |
| Contact: Stefan Denzinger, MD +49 941-782 3510 stefandenzinger@hotmail.com | |
| Principal Investigator: Wolfgang Rössler, MD | |
| Sub-Investigator: Maximillian Burger, MD | |
| Sub-Investigator: Stefan Denzinger, MD | |
| Universitätsklinik Tuebingen, Universitätsklinik für Urologie | Enrolling by invitation |
| Tuebingen, Germany, 72076 | |
| Netherlands | |
| Department of Urology, Academic Medical Center, University of Amsterdam | Enrolling by invitation |
| Amsterdam, Netherlands, 1105 AZ | |
| Department of Urology, UMC St. Radboud | Recruiting |
| Nijmegen, Netherlands, 6500 HB | |
| Contact: Fred Witjes, MD +31 24 361 6712 F.Witjes@uro.umcn.nl | |
| Principal Investigator: Fred Witjes, MD | |
| Sub-Investigator: Martine Ploeg, MD | |
Sponsors and Collaborators
PhotoCure
Investigators
| Principal Investigator: | Herbert Barton Grossman, MD | The University of Texas, MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Mona Welschof, Photocure ASA |
| ClinicalTrials.gov Identifier: | NCT01166230 History of Changes |
| Other Study ID Numbers: | PC B305/E10 |
| Study First Received: | July 19, 2010 |
| Last Updated: | July 19, 2010 |
| Health Authority: | United States: Institutional Review Board Canada: Ethics Review Committee Austria: Ethikkommission Netherlands: Medical Ethics Review Committee (METC) Germany: Ethics Commission |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Recurrence Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Neoplasms Urinary Bladder Diseases Urologic Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013