Multi Center Study to Obtain Bladder Tissue Specimens From Patients Undergoing Transurethral Resection Biopsy Procedure
Overview
The objective of the study is to obtain bladder tissue specimens from patients otherwise undergoing cystoscopy for use in research at Tengion, Inc.
Full Title of Study: “A Multi Center Study to Obtain Bladder Tissue Specimens From Subjects Undergoing Transurethral Resection of Bladder Tumor (TURBT) or Other Transurethral Biopsy Procedures”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: September 2008
Interventions
- Procedure: Bladder biopsy
- provision of bladder tissue via cystoscopic biopsy during planned TURBT
Arms, Groups and Cohorts
- TURBT group
- Subjects undergoing transurethral resection of bladder tumor or other transurethral biopsy procedure who agree to provide bladder tissue specimens
Clinical Trial Outcome Measures
Primary Measures
- Evaluation of bladder tissue from patients undergoing transurethral resection of bladder tumor or other transurethral biopsy procedure
- Time Frame: ongoing throughout study
Participating in This Clinical Trial
Inclusion Criteria
- Subjects 18-90 years and undergoing TURBT – Willing and able to give signed informed consent Exclusion Criteria:
- Known active infection – Known colonization with MRSA or VRE – Receipt of blood or blood products for transfusion during the previous 3 months
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 90 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Tengion
- Provider of Information About this Clinical Study
- Sunita Sheth, MD Chief Medical Officer, Tengion, Inc
- Overall Official(s)
- Sunita Sheth, MD, Study Director, Tengion, Inc
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