Longer-term Recurrence Rates in Patients With Bladder Cancer After Hexvix (Cysview)Fluorescence Cystoscopy/TURB
Recruitment status was Recruiting
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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 |
|---|
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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 |
- 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 |
|---|
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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.
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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 |
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.
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
Show 23 Study Locations| 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 23, 2013