Multi Center Study to Obtain Bladder Tissue Specimens From Patients Undergoing Transurethral Resection Biopsy Procedure
A Multi Center Study to Obtain Bladder Tissue Specimens From Subjects Undergoing Transurethral Resection of Bladder Tumor (TURBT) or Other Transurethral Biopsy Procedures
1 other identifier
observational
6
1 country
1
Brief Summary
The objective of the study is to obtain bladder tissue specimens from patients otherwise undergoing cystoscopy for use in research at Tengion, Inc.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2008
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2008
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedFirst Posted
Study publicly available on registry
February 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedDecember 22, 2010
December 1, 2010
7 months
February 1, 2008
December 20, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of bladder tissue from patients undergoing transurethral resection of bladder tumor or other transurethral biopsy procedure
ongoing throughout study
Study Arms (1)
TURBT group
Subjects undergoing transurethral resection of bladder tumor or other transurethral biopsy procedure who agree to provide bladder tissue specimens
Interventions
provision of bladder tissue via cystoscopic biopsy during planned TURBT
Eligibility Criteria
Patients otherwise undergoing TURBT
You may qualify if:
- Subjects 18-90 years and undergoing TURBT
- Willing and able to give signed informed consent
You may not qualify if:
- Known active infection
- Known colonization with MRSA or VRE
- Receipt of blood or blood products for transfusion during the previous 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tengionlead
Study Sites (1)
University of Alabama, Birmingham
Birmingham, Alabama, 35233, United States
Biospecimen
Tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sunita Sheth, MD
Tengion, Inc
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 1, 2008
First Posted
February 14, 2008
Study Start
February 1, 2008
Primary Completion
September 1, 2008
Study Completion
December 1, 2008
Last Updated
December 22, 2010
Record last verified: 2010-12