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Spots Global Cancer Trial Database for Blue Light Cystoscopy With Cysview® Registry

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Trial Identification

Brief Title: Blue Light Cystoscopy With Cysview® Registry

Official Title: Blue Light Cystoscopy With Cysview® Registry

Study ID: NCT02660645

Conditions

Bladder Cancer

Study Description

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

Detailed 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. 1. 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? 2. 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? 3. 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? 4. 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? 5. 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)? 6. 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? 7. Does an abnormal urinalysis help identify patients with inflammation more likely to have false positive Blue Light Cystoscopy with Cysview results? 8. What is the practical learning curve for becoming "proficient" with Blue Light Cystoscopy with Cysview? 9. What is the overall false positive rate with Blue Light Cystoscopy with Cysview? 10. 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

The University of Alabama at Birmingham, Birmingham, Alabama, United States

Mayo Clinic, Phoenix, Arizona, United States

USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States

University of California Los Angeles, Los Angeles, California, United States

VA Palo Alto Health Care System, Palo Alto, California, United States

University of California, San Francisco, San Francisco, California, United States

Sibley Memorial Hospital, Washington, District of Columbia, United States

Emory University School of Medicine, Atlanta, Georgia, United States

Indiana University School of Medicine, Indianapolis, Indiana, United States

University of Kansas Medical Center, Kansas City, Kansas, United States

Johns Hopkins Medicine, Baltimore, Maryland, United States

University of Minnesota, Minneapolis, Minnesota, United States

NYU Langone's Perlmutter Cancer Center, New York, New York, United States

Stony Brook Urology, Stony Brook, New York, United States

Ohio State University Wexner Medical Center, Columbus, Ohio, United States

Ohio State University, Columbus, Ohio, United States

Lexington Medical Center, West Columbia, South Carolina, United States

UT Southwestern, Dallas, Texas, United States

Michael E. DeBakey VA Medical Center, Houston, Texas, United States

University of Washington Medicine, Seattle, Washington, United States

Charleston Area Medical Center, Charleston, West Virginia, United States

Contact Details

Name: Siamak Daneshmand, MD

Affiliation: University of Southern California

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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