Bladder Cancer Clinical Trial

Blue Light Cystoscopy With Cysview® Registry

Summary

Registry study to gather more information on the current use of Blue Light Cystoscopy with Cysview (BLCC) in urologists' practices.

View Full Description

Full Description

Data will be captured on specific patient types undergoing Blue Light Cystoscopy with Cysview for known or suspected non-muscle invasive bladder cancer. Specific clinical questions will be asked.

What is the incremental detection rate with Blue Light Cystoscopy with Cysview over conventional white light cystoscopy in each of the seven (7) patient populations? Does this translate into lower recurrence/progression rate?
How do the six (6) tumor variables used in the European Association of Urology (EAU) risk tables (primary/secondary, recurrence rate, size, multifocality, grade, and history of carcinoma in situ (CIS))6 affect this incremental rate?
How does an abnormal cytology or positive or negative fluorescent in situ hybridization (FISH) affect the likelihood that Blue Light Cystoscopy with Cysview will detect more cancers than white light?
What are the performance characteristics of Blue Light Cystoscopy with Cysview within eight (8) weeks of Bacillus Calmette-Guérin (BCG) with respect to improved tumor detection and false positive rate compared to conventional white light cystoscopy?
What is the incremental Blue Light Cystoscopy with Cysview detection rate over random bladder biopsies alone in patients being evaluated for routine three month restaging (group 4) or occult disease (group 5)?
What are the performance characteristics of Blue Light Cystoscopy with Cysview after repeated Blue Light Cystoscopy with Cysview evaluations with respect to improved tumor detection, false positive rate and safety compared to conventional white light?
Does an abnormal urinalysis help identify patients with inflammation more likely to have false positive Blue Light Cystoscopy with Cysview results?
What is the practical learning curve for becoming "proficient" with Blue Light Cystoscopy with Cysview?
What is the overall false positive rate with Blue Light Cystoscopy with Cysview?
Can Blue Light Cystoscopy with Cysview make the resection more complete? If yes, is this due to improved margins and/or additional tumors seen under blue light?

The Blue Light Cystoscopy with Cysview Registry is a web-based program supported by Global Vision Technologies. Data will be captured longitudinally over five (5) years on patients from each enrolled site. Each center will enter their respective site's patient data electronically.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Adult >18 years old
Suspected or known non-muscle invasive bladder cancer on the basis of a prior cystoscopy

Exclusion Criteria:

Porphyria
Gross hematuria
Known hypersensitivity to hexaminolevulinate or aminolevulinate derivatives

Study is for people with:

Bladder Cancer

Estimated Enrollment:

4400

Study ID:

NCT02660645

Recruitment Status:

Recruiting

Sponsor:

Photocure

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There are 20 Locations for this study

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The University of Alabama at Birmingham
Birmingham Alabama, 35294, United States More Info
Charles Peyton, MD
Contact
[email protected]
Charles Peyton, MD
Principal Investigator
Mayo Clinic
Phoenix Arizona, 85054, United States More Info
Mark Tyson, MD, MPH
Contact
[email protected]
Mark Tyson, MD, MPH
Principal Investigator
USC/Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States More Info
Ileana Aldana
Contact
323-865-0702
[email protected]
Sia Daneshmand, MD
Principal Investigator
Anne Schuckman, MD
Sub-Investigator
Mihir Desai, MD
Sub-Investigator
Hooman Djaladat, MD
Sub-Investigator
Gerhard Fuchs, MD
Sub-Investigator
Virinder Bhardwaj, MD
Sub-Investigator
University of California Los Angeles
Los Angeles California, 90095, United States More Info
Karim Chamie, MD
Contact
310-794-7700
Karim Chamie, MD
Principal Investigator
VA Palo Alto Health Care System
Palo Alto California, 94304, United States More Info
Dorothy Trivedi
Contact
[email protected]
Joseph Liao, MD
Principal Investigator
James Crotty, MD
Sub-Investigator
John Leppert, MD
Sub-Investigator
John Lavelle, MD
Sub-Investigator
University of California, San Francisco
San Francisco California, 94143, United States More Info
Sima Porten, MD, MPH
Contact
415-885-3695
[email protected]
Sima Porten, MD, MPH
Principal Investigator
Sibley Memorial Hospital
Washington District of Columbia, 20016, United States More Info
Armine Smith, MD
Contact
202-660-5561
Armine Smith, MD
Principal Investigator
Emory University School of Medicine
Atlanta Georgia, 30097, United States More Info
Vikram Narayan, MD
Contact
404-778-4898
Vikram Narayan, MD
Principal Investigator
Shreyas Joshi, MD
Sub-Investigator
Indiana University School of Medicine
Indianapolis Indiana, 46202, United States More Info
Lehman G Jennifer, RN, CCRP
Contact
[email protected]
Hristos Z Kaimakliotis, MD
Principal Investigator
University of Kansas Medical Center
Kansas City Kansas, 66160, United States More Info
Jane Ledesma
Contact
913-588-8721
[email protected]
John Taylor, MD, MS
Principal Investigator
Jeffrey Holzbeierlein, MD, FACS
Sub-Investigator
Johns Hopkins Medicine
Baltimore Maryland, 21224, United States More Info
Morgan De Carli
Contact
[email protected]
Max Kates, MD
Principal Investigator
University of Minnesota
Minneapolis Minnesota, 55455, United States More Info
Maressa Twedt
Contact
612-626-6661
[email protected]
Hamed Ahmadi, MD
Principal Investigator
Subodh Regmi, MD
Sub-Investigator
NYU Langone's Perlmutter Cancer Center
New York New York, 10016, United States More Info
Gary Steinberg, MD
Contact
646-825-6300
Gary Steinberg, MD
Principal Investigator
Stony Brook Urology
Stony Brook New York, 11794, United States
Ohio State University Wexner Medical Center
Columbus Ohio, 43210, United States More Info
Kamal Pohar, MD
Contact
[email protected]
Kamal Pohar, MD
Principal Investigator
Megan Merrill, DO
Sub-Investigator
Ahmad Shabsigh, MD
Sub-Investigator
David Sharp, MD
Sub-Investigator
Ohio State University
Columbus Ohio, 43210, United States More Info
Rachel Link, CCRP
Contact
[email protected]
Kamal S Pohar, MD
Principal Investigator
Lexington Medical Center
West Columbia South Carolina, 29169, United States More Info
Nicol Brandon
Contact
704-414-2870
[email protected]
T. Brian Willard, MD
Principal Investigator
David Lamb, MD
Sub-Investigator
Scott Sweazy, MD
Sub-Investigator
Keith Birghtbill, MD
Sub-Investigator
Michael Stotzer, MD
Sub-Investigator
UT Southwestern
Dallas Texas, 75390, United States More Info
Yair Lotan, MD
Contact
214-645-8787
Yair Lotan, MD
Principal Investigator
Aditya Bagrodia, MD
Sub-Investigator
Michael E. DeBakey VA Medical Center
Houston Texas, 77030, United States More Info
Ashley Jones, BS, CCRP
Contact
713-791-1414
[email protected]
Jennifer Taylor, MD, MPH
Principal Investigator
Jeffrey Jones, MD
Sub-Investigator
Sidney Worsham, MD
Sub-Investigator
University of Washington Medicine
Seattle Washington, 98195, United States More Info
John Gore, MD
Contact
206-598-4294
John Gore, MD
Principal Investigator
Charleston Area Medical Center
Charleston West Virginia, 25301, United States

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Estimated Enrollment:

4400

Study ID:

NCT02660645

Recruitment Status:

Recruiting

Sponsor:


Photocure

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