Bladder Cancer Clinical Trial
— BLCCROfficial title:
Blue Light Cystoscopy With Cysview® Registry
NCT number | NCT02660645 |
Other study ID # | BLCCR-001 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 2014 |
Est. completion date | December 2028 |
Registry study to gather more information on the current use of Blue Light Cystoscopy with Cysview (BLCC) in urologists' practices.
Status | Recruiting |
Enrollment | 4400 |
Est. completion date | December 2028 |
Est. primary completion date | December 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Emory University School of Medicine | Atlanta | Georgia |
United States | Johns Hopkins Medicine | Baltimore | Maryland |
United States | The University of Alabama at Birmingham | Birmingham | Alabama |
United States | Charleston Area Medical Center | Charleston | West Virginia |
United States | Ohio State University | Columbus | Ohio |
United States | Ohio State University Wexner Medical Center | Columbus | Ohio |
United States | UT Southwestern | Dallas | Texas |
United States | Michael E. DeBakey VA Medical Center | Houston | Texas |
United States | Indiana University School of Medicine | Indianapolis | Indiana |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | University of California Los Angeles | Los Angeles | California |
United States | USC/Norris Comprehensive Cancer Center | Los Angeles | California |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | NYU Langone's Perlmutter Cancer Center | New York | New York |
United States | VA Palo Alto Health Care System | Palo Alto | California |
United States | Mayo Clinic | Phoenix | Arizona |
United States | University of California, San Francisco | San Francisco | California |
United States | University of Washington Medicine | Seattle | Washington |
United States | Stony Brook Urology | Stony Brook | New York |
United States | Sibley Memorial Hospital | Washington | District of Columbia |
United States | Lexington Medical Center | West Columbia | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Photocure | Catalyst Pharmaceutical Research |
United States,
Ahmadi H, Ladi-Seyedian SS, Konety B, Pohar K, Holzbeierlein JM, Kates M, Willard B, Taylor JM, Liao JC, Kaimakliotis HZ, Porten SP, Steinberg GD, Tyson MD, Lotan Y, Daneshmand S; Blue Light Cystoscopy with Cysview Registry Group. Role of blue-light cysto — View Citation
Alsyouf M, Ladi-Seyedian SS, Konety B, Pohar K, Holzbeierlein JM, Kates M, Willard B, Taylor JM, Liao JC, Kaimakliotis HZ, Porten SP, Steinberg GD, Tyson MD, Lotan Y, Daneshmand S; Blue Light Cystoscopy with Cysview Registry Group. Is a restaging TURBT ne — View Citation
Bazargani ST, Shah SH, Djaladat H, et al. Blue Light Cystoscopy For Diagnosis of Urothelial Bladder Cancer: Results: From A Prospective Registry. Poster presented at: The Annual meeting of Society of Urologic Oncology; December 2015; Washington, D.C.
Chappidi MR, Yang H, Meng MV, Bivalacqua TJ, Daneshmand S, Holzbeierlein JM, Kaimakliotis HZ, Konety B, Liao JC, Pohar K, Steinberg GD, Taylor JM, Tyson MD, Willard B, Lotan Y, Porten SP, Kates M. Utility of Blue Light Cystoscopy for Post-bacillus Calmett — View Citation
Daneshmand S, Bazargani ST, Bivalacqua TJ, Holzbeierlein JM, Willard B, Taylor JM, Liao JC, Pohar K, Tierney J, Konety B; Blue Light Cystoscopy with Cysview Registry Group. Blue light cystoscopy for the diagnosis of bladder cancer: Results from the US pro — View Citation
Daneshmand S, Patel S, Lotan Y, Pohar K, Trabulsi E, Woods M, Downs T, Huang W, Jones J, O'Donnell M, Bivalacqua T, DeCastro J, Steinberg G, Kamat A, Resnick M, Konety B, Schoenberg M, Jones JS; Flexible Blue Light Study Group Collaborators. Efficacy and — View Citation
Matulewicz RS, Ravvaz K, Weissert JA, Porten S, Steinberg GD; Blue Light Cystoscopy with Cysview Registry Group. Association of smoking status and recurrence of non-muscle invasive bladder cancer among patients managed with blue light cystoscopy. Urol Onc — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of detection of bladder malignancies | Rate of detection of bladder malignancies with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone. | 5 years | |
Secondary | False-positive detection rates | Rates of false-positive lesion biopsies based on pathological findings | 5 years | |
Secondary | Higher-Quality resection rates with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone | Rate of additional margin detection with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone | 5 years | |
Secondary | Proportion of patients with adverse events considered causally related to Cysview in repeat administration. | Adverse events reporting | 5 years | |
Secondary | Recurrence Rates | Recurrence rates NMIBC in patients whose lesions were detected with Blue Light Cystoscopy with Cysview | 5 years | |
Secondary | Cystectomy Rate | Proportion of patients who have a cystectomy performed | 5 years |
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