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

This study has been completed.
Information provided by:
Tengion Identifier:
First received: February 1, 2008
Last updated: December 20, 2010
Last verified: December 2010

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

Condition Intervention
Bladder Disease
Procedure: Bladder biopsy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by Tengion:

Primary Outcome Measures:
  • Evaluation of bladder tissue from patients undergoing transurethral resection of bladder tumor or other transurethral biopsy procedure [ Time Frame: ongoing throughout study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA


Enrollment: 6
Study Start Date: February 2008
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
TURBT group
Subjects undergoing transurethral resection of bladder tumor or other transurethral biopsy procedure who agree to provide bladder tissue specimens
Procedure: Bladder biopsy
provision of bladder tissue via cystoscopic biopsy during planned TURBT


Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients otherwise undergoing TURBT


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
  Contacts and Locations
Please refer to this study by its identifier: NCT00615043

United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
Study Director: Sunita Sheth, MD Tengion, Inc
  More Information

No publications provided

Responsible Party: Sunita Sheth, MD Chief Medical Officer, Tengion, Inc Identifier: NCT00615043     History of Changes
Other Study ID Numbers: TNG-CL007
Study First Received: February 1, 2008
Last Updated: December 20, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Tengion:
Transurethral resection of bladder tumor

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urinary Bladder Diseases
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urologic Diseases processed this record on April 15, 2014