Endoscopic Resection of Bladder Tumors
Endoscopic Resection of High Grade(TA, T1, Cis)Non-muscle Invasive Bladder Tumors: Modification of Usual Management of This Resection by Using the Blue Light and Evaluation of the Outcome: Should we Maintain the Dogma of Second Endoscopic Resection as a Principle?
1 other identifier
interventional
68
1 country
1
Brief Summary
To confirm the benefit of endoscopic resection under fluorescence and blue light of high grade non-muscle invasive bladder tumor, and verifying if the second endoscopic resection recommended nowadays can be deleted.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 11, 2012
CompletedFirst Posted
Study publicly available on registry
December 17, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedSeptember 21, 2016
September 1, 2016
3.1 years
December 11, 2012
September 20, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of extra lesions revealed by blue light compared to the resection performed in white light
2 to 6 weeks after resection
Study Arms (2)
Resection under blue light
EXPERIMENTALResection under white light
ACTIVE COMPARATORInterventions
Endoscopic resection
Eligibility Criteria
You may qualify if:
- \- 18 year-old and older male and female subjects having high grade non-muscle invasive bladder tumor, with urinary cytology , imaging examination (Ultrasound, urography, or scan) and endoscopic examination
You may not qualify if:
- \- Less than 18 years of age, and having no:
- Non-muscle invasive tumor, and of low grade.
- Bladder tumor infiltrating the muscular layer shown by pre-operative test, with absence of urinary cytology
- No blue light source in sustainable way
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
Study Sites (1)
Hôpital FOCH
Suresnes, 92150, France
Related Publications (1)
Neuzillet Y, Methorst C, Schneider M, Lebret T, Rouanne M, Radulescu C, Molinie V, Dreyfus JF, Pelcat V, Botto H. Assessment of diagnostic gain with hexaminolevulinate (HAL) in the setting of newly diagnosed non-muscle-invasive bladder cancer with positive results on urine cytology. Urol Oncol. 2014 Nov;32(8):1135-40. doi: 10.1016/j.urolonc.2014.04.005. Epub 2014 Jul 9.
PMID: 25023786DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henry BOTTO, MD
Hôpital FOCH 40, rue Worth 92150 Suresnes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2012
First Posted
December 17, 2012
Study Start
November 1, 2009
Primary Completion
December 1, 2012
Study Completion
December 1, 2013
Last Updated
September 21, 2016
Record last verified: 2016-09