Blue Light Cystoscopy With Cysview® Registry

Active:	Yes
Cancer Type:	Bladder Cancer	NCT ID:	NCT02660645
Trial Phases:		Protocol IDs:	BLCCR-001 (primary) NCI-2018-00299
Eligibility:	18 Years and older, Male and Female	Study Type:	Other
Study Sponsor:	Photocure ASA
NCI Full Details:	http://clinicaltrials.gov/show/NCT02660645

Summary

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

Objectives

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.

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.