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

This study has been completed.

First Received: February 1, 2008 Last Updated: February 26, 2009 History of Changes

Sponsored by:	Tengion
Information provided by:	Tengion
ClinicalTrials.gov Identifier:	NCT00615043

Purpose

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

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Bladder Diseases Cancer

Study Type:	Observational
Study Design:	Case-Only, 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

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

Biospecimen Description:

Tissue

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
A 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

Eligibility

Study Population

Patients otherwise undergoing TURBT

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615043

Locations

United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35233

Sponsors and Collaborators

Tengion

Investigators

Study Director:

Elyse G Seltzer, MD

Tengion, Inc

More Information

No publications provided

Responsible Party:	Tengion, Inc ( Elyse Selzter, MD, Vice President of Clinical Development and Medical Affairs )
Study ID Numbers:	TNG-CL007
Study First Received:	February 1, 2008
Last Updated:	February 26, 2009
ClinicalTrials.gov Identifier:	NCT00615043 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Tengion:

Transurethral resection of bladder tumor
TURBT

Study placed in the following topic categories:

Cystocele
Urologic Diseases
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Bladder Neoplasm

Additional relevant MeSH terms:

Cystocele
Urologic Diseases
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on May 07, 2009