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NCT00615043 Clinical Trial

Multi Center Study to Obtain Bladder Tissue Specimens From Patients Undergoing Transurethral Resection Biopsy Procedure

Bladder Disease Clinical Trial

Official title:
A Multi Center Study to Obtain Bladder Tissue Specimens From Subjects Undergoing Transurethral Resection of Bladder Tumor (TURBT) or Other Transurethral Biopsy Procedures

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00615043
Other study ID # TNG-CL007
Secondary ID
Status Completed
Phase N/A
First received February 1, 2008
Last updated December 20, 2010
Start date February 2008
Est. completion date December 2008

Study information
Verified date December 2010
Source Tengion
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

The objective of the study is to obtain bladder tissue specimens from patients otherwise undergoing cystoscopy for use in research at Tengion, Inc.

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date December 2008
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Bladder biopsy
provision of bladder tissue via cystoscopic biopsy during planned TURBT

Locations
Country Name City State
United States University of Alabama, Birmingham Birmingham Alabama

Sponsors (1)
Lead Sponsor Collaborator
Tengion

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of bladder tissue from patients undergoing transurethral resection of bladder tumor or other transurethral biopsy procedure ongoing throughout study No
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